Trial · NCT00927082
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
NCT00927082, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B. Trials, record NCT00927082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00927082
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
- NCT number
- NCT00927082
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 383 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis B, Chronic
- Interventions
- peginterferon alfa-2a [Pegasys]
- First posted
- 2009-06-24
- Last updated
- 2016-03-09
- Results first posted
- 2016-03-09
- Limitations and caveats
Of the responders at FU Year 5, the proportion of patients who were receiving additional anti-HBV treatment after FU Week 24 varied between groups.~The frequency of missing values (counted as non-response) was unevenly distributed between groups.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | Annually, for up to 5 years | HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response. |
| Primary | Percentage of Participants With HBsAg Loss | Annually, for up to 5 years | HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response. |
| Secondary | Percentage of Participants With HBeAg Loss. | Annually, for up to 5 years | HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion. | Annually, for up to 5 years | HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe). | Annually, for up to 5 years | The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Presence of Anti-HBs | Annually, for up to 5 years | The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Normalised Alanine Transaminase (ALT) | Annually, for up to 5 years | Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL). | Annually, for up to 5 years | The percentage of participants with HBV-DNA suppression \< 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL) | Annually, for up to 5 years | The percentage of participants with HBV-DNA suppression \< 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response. |
| Secondary | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL) | Annually, for up to 5 years | The percentage of participants with HBV-DNA suppression \< 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | Annually, for up to 5 years | The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss. | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion. | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe). | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Presence of Anti-HBs | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normalised Alanine Transaminase (ALT) | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With HBsAg Loss | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL). | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL) | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL) | Annually, for up to 5 years | The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis. | Percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group468
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 Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 90mcg 24 Wks | End of Treatment (EOT) | 9.7 | 95% Confidence Interval 4.5 to 17.6 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 180mcg 24 Wks | End of Treatment (EOT) | 14.6 | 95% Confidence Interval 8.0 to 23.7 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 90mcg 48 Wks | End of Treatment (EOT) | 19.8 | 95% Confidence Interval 12.7 to 28.7 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 180mcg 48 Wks | End of Treatment (EOT) | 31.6 | 95% Confidence Interval 22.4 to 41.9 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 90mcg 24 Wks | FU Year 1 | 20.4 | 95% Confidence Interval 12.8 to 30.1 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 180mcg 24 Wks | FU Year 1 | 31.5 | 95% Confidence Interval 22.0 to 42.2 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 90mcg 48 Wks | FU Year 1 | 27.4 | 95% Confidence Interval 19.1 to 36.9 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 180mcg 48 Wks | FU Year 1 | 35.8 | 95% Confidence Interval 26.2 to 46.3 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 90mcg 24 Wks | FU Year 2 | 26.9 | 95% Confidence Interval 18.2 to 37.1 | Percentage of participants |
| Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. | PEG-IFN 180mcg 24 Wks | FU Year 2 | 37.1 | 95% Confidence Interval 27.1 to 48.0 | Percentage of participants |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEG-IFN 90mcg 24 Wks | 91 | |
| Overall Study | STARTED | PEG-IFN 180mcg 24 Wks | 87 | |
| Overall Study | STARTED | PEG-IFN 90mcg 48 Wks | 108 | |
| Overall Study | STARTED | PEG-IFN 180mcg 48 Wks | 97 | |
| Overall Study | COMPLETED | PEG-IFN 90mcg 24 Wks | 79 | |
| Overall Study | COMPLETED | PEG-IFN 180mcg 24 Wks | 77 | |
| Overall Study | COMPLETED | PEG-IFN 90mcg 48 Wks | 86 | |
| Overall Study | COMPLETED | PEG-IFN 180mcg 48 Wks | 78 | |
| Overall Study | NOT COMPLETED | PEG-IFN 90mcg 24 Wks | 12 | |
| Overall Study | NOT COMPLETED | PEG-IFN 180mcg 24 Wks | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Upper respiratory tract infection | Infections and infestations | PEG-IFN 90mcg 24 Wks | 5 | 93 | |
| other | Upper respiratory tract infection | Infections and infestations | PEG-IFN 180mcg 24 Wks | 6 | 89 | |
| other | Upper respiratory tract infection | Infections and infestations | PEG-IFN 90mcg 48 Wks | 4 | 106 | |
| other | Upper respiratory tract infection | Infections and infestations | PEG-IFN 180mcg 48 Wks | 7 | 95 | |
| other | Alanine aminotransferase increased | Investigations | PEG-IFN 90mcg 24 Wks | 3 | 93 | |
| other | Alanine aminotransferase increased | Investigations | PEG-IFN 180mcg 24 Wks | 2 | 89 | |
| other | Alanine aminotransferase increased | Investigations | PEG-IFN 90mcg 48 Wks | 4 | 106 | |
| other | Alanine aminotransferase increased | Investigations | PEG-IFN 180mcg 48 Wks | 5 | 95 | |
| serious | Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PEG-IFN 90mcg 24 Wks | 1 | 93 | |
| serious | Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | PEG-IFN 180mcg 24 Wks | 0 | 89 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG-IFN 90mcg 24 Wks | ||
| Total, all-cause mortality | PEG-IFN 180mcg 24 Wks | ||
| Total, all-cause mortality | PEG-IFN 90mcg 48 Wks | ||
| Total, all-cause mortality | PEG-IFN 180mcg 48 Wks | ||
| Total, other adverse events | PEG-IFN 90mcg 24 Wks | 8 | 93 |
| Total, other adverse events | PEG-IFN 180mcg 24 Wks | 8 | 89 |
| Total, other adverse events | PEG-IFN 90mcg 48 Wks | 8 | 106 |
| Total, other adverse events | PEG-IFN 180mcg 48 Wks | 12 | 95 |
| Total, serious adverse events | PEG-IFN 90mcg 24 Wks | 5 | 93 |
| Total, serious adverse events | PEG-IFN 180mcg 24 Wks | 4 | 89 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00927082
GET https://conductscience.org/api/trials/v1/NCT00927082/results?page=2