Trial · NCT01066819
PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
NCT01066819, Completed, Hoffmann-La Roche; results first posted 2016-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b. Trials, record NCT01066819. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01066819
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PROPHESYS 3: Observational Study on Predictors of Response in Patients With Treatment-naïve Chronic Hepatitis C Initiated on Treatment With Pegasys (Peginterferon Alfa-2a) or Peginterferon-alfa-2b
- NCT number
- NCT01066819
- Status
- Completed
- Enrollment
- 1,656 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- Peginterferon alfa-2a [Pegasys], Peginterferon alfa-2b [PegIntron®]
- First posted
- 2010-02-10
- Last updated
- 2016-08-08
- Results first posted
- 2016-08-08
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks (Wk) after EOT | Sustained virological response (SVR) was defined as virological response (VR) at 24 weeks after end of treatment (EOT). Virological response was defined as hepatitis C virus ribonucleic acid (HCV RNA) of \<15 international units per milliliter (IU/mL) as assessed by COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection \[LLOD\] 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected modified all-treated (mTRT) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Primary | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | Sustained virological response was defined as VR at 24 weeks after EOT. Virological response was defined as HCV RNA of \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The SVR is reported in treatment naive HCV mono-infected per protocol (PP) population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Primary | Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks after EOT | Modified sustained virological response (mSVR) was defined as modified virological response (mVR) of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Primary | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | Modified sustained virological response is defined as mVR of HCV RNA \<50 IU/mL at 24 weeks after EOT. The mSVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Primary | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | At 24 weeks after EOT | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the positive predictive value (PPV) of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the negative predictive value (NPV) of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected mTRT participants who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Primary | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | At 24 weeks after EOT | The probability that a participant who developed VR by Week 4 and 12 and also achieved mSVR at 24 weeks after EOT was called the PPV of the VR by Wk 4 for mSVR. The probability that a participant who failed to develop VR by Wk 4 and 12 and also failed to achieve mSVR at 24 weeks after EOT was called the NPV of the VR by Wk 4 and 12 for mSVR. Predictive values of VR are reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. |
| Secondary | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | Virological Response (VR) was defined as HCV RNA \<15 IU/mL as assessed by COBAS AmpliPrep/COBAS TaqMan (HCV) (CAP/CTM) or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (lower limit of detection 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. PEOT= Post End of Treatment. EOT= 12, 24, 48 or 72 weeks after initiation of treatment. |
| Secondary | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | Virological response (VR) was defined as HCV RNA \<15 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The VR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment |
| Secondary | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | Modified virological response (mVR) was defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected mTRT population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment |
| Secondary | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | Modified virological response (mVR) is defined as HCV RNA \<50 IU/mL as assessed by CAP/CTM or another HCV RNA test with at least the same degree of sensitivity. The CAP/CTM test is an in vitro nucleic acid amplification test for the quantification of HCV. This test possesses a high sensitivity (LLOD 15 IU/mL) and a broad linear range of quantification (43 IU/mL up to 69 million IU/mL) in all HCV genotypes. The mVR is reported in treatment naive HCV mono-infected PP population who received PEG-IFN alfa-2a and PEG-IFN alfa-2b. The EOT was 12, 24, 48 or 72 weeks after initiation of treatment. PEOT= Post End of Treatment |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks (Wk) after EOT | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline (BL) result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | The per-protocol (PP) population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Modified Sustained Virological Response Over Time by Type of Peginterferon and Genotype in Modified All Treated Population | At 24 weeks after EOT | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result \<50 international units per millilitre (IU/mL) were excluded. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Modified Sustained Virological Response by Type of Peginterferon and Genotype in Per Protocol Population | At 24 weeks after EOT | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Modified All Treated Population | At 24 weeks after EOT | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Predictive Values of Virological Response by Week 4 and 12 on Modified Sustained Virological Response After Treatment Initiation in Per Protocol Population | At 24 weeks after EOT | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | The mTRT population included all participants who received at least one dose of PEG-IFN and ribavirin, and had at least one post-baseline HCV RNA result. Participants with a baseline result \<50 IU/mL were excluded. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Modified Virological Response by Type of Peginterferon and Genotype in Per Protocol Population Over Time | At Week 2, Week 4, Week 12, EOT, and at 12 Weeks after EOT | The PP population included all participants who met the inclusion and exclusion criteria of the study. n = the number of participants analyzed at a given time point. | percentage of participants | NUMBER |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group662
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 1 (G1) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 30.3 | 95% Confidence Interval 26.5 to 34.2 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 2 (G2) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 55.7 | 95% Confidence Interval 48.8 to 62.3 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 3 (G3) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 43.4 | 95% Confidence Interval 35.6 to 51.5 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 4 (G4) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 31.3 | 95% Confidence Interval 11.0 to 58.7 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 5/6 (G5/6) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 100.0 | 95% Confidence Interval 15.8 to 100.0 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype Unknown (UNK) | Peg IFN Alfa 2a (n=568,221,159,16,2,1) | 0.0 | 95% Confidence Interval 0.0 to 97.5 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 1 (G1) | Peg IFN Alfa 2b (n=106,46,29,2,1,1) | 23.6 | 95% Confidence Interval 15.9 to 32.8 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 2 (G2) | Peg IFN Alfa 2b (n=106,46,29,2,1,1) | 50.0 | 95% Confidence Interval 34.9 to 65.1 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 3 (G3) | Peg IFN Alfa 2b (n=106,46,29,2,1,1) | 37.9 | 95% Confidence Interval 20.7 to 57.7 | percentage of participants |
| Percentage of Participants With Sustained Virological Response by Type of Peginterferon and Genotype in Modified All Treated Population | Genotype 4 (G4) | Peg IFN Alfa 2b (n=106,46,29,2,1,1) | 50.0 | 95% Confidence Interval 1.3 to 98.7 | percentage of participants |
1 to 10 of 662Source ClinicalTrials.gov
See all 662 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genotype 1 (G1) | 1,006 | |
| Overall Study | STARTED | Genotype 2 (G2) | 348 | |
| Overall Study | STARTED | Genotype 3 (G3) | 257 | |
| Overall Study | STARTED | Genotype 4 (G4) | 25 | |
| Overall Study | STARTED | Genotype 5/6 (G5/6) | 7 | |
| Overall Study | STARTED | Genotype Unknown (UNK) | 13 | |
| Overall Study | COMPLETED | Genotype 1 (G1) | 317 | |
| Overall Study | COMPLETED | Genotype 2 (G2) | 177 | |
| Overall Study | COMPLETED | Genotype 3 (G3) | 111 | |
| Overall Study | COMPLETED | Genotype 4 (G4) | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Depression | Psychiatric disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 234 | 1,441 | |
| other | Insomnia | Psychiatric disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 224 | 1,441 | |
| other | Anxiety | Psychiatric disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 92 | 1,441 | |
| other | Anaemia | Blood and lymphatic system disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 333 | 1,441 | |
| other | Neutropenia | Blood and lymphatic system disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 108 | 1,441 | |
| other | Fatigue | General disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 206 | 1,441 | |
| other | Influenza like illness | General disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 104 | 1,441 | |
| other | Irritability | General disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 74 | 1,441 | |
| other | Rash | Skin and subcutaneous tissue disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 138 | 1,441 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 80 | 1,441 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | ||
| Total, other adverse events | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 841 | 1,441 |
| Total, serious adverse events | Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b) | 130 | 1,441 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24329937 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01066819/registered?page=2