Trial · NCT02106156
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
NCT02106156, Completed, Hoffmann-La Roche; results first posted 2016-09-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists). Trials, record NCT02106156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106156
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
- NCT number
- NCT02106156
- Status
- Completed
- Enrollment
- 10,228 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Chronic Hepatitis C
- Interventions
- Pegylated interferon alfa-2a, Ribavirin
- First posted
- 2014-04-08
- Last updated
- 2016-09-23
- Results first posted
- 2016-09-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Rapid Virologic Response (RVR) | At Week 4 | RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4. |
| Primary | Percentage of Participants With Early Virologic Response (EVR) | At Week 12 | EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12. |
| Primary | Percentage of Participants With End of Treatment (EOT) Response | Up to Week 72 | EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment. |
| Primary | Percentage of Participants With Sustained Virologic Response (SVR) | Up to Week 96 | SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment. |
| Primary | Percentage of Participants With Serious Adverse Drug Reactions (SADR) | Up to Week 96 | |
| Secondary | Percentage Cumulative Dose of Peginterferon Alfa-2a Received | Up to Week 96 | Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period. |
| Secondary | Percentage Cumulative Dose of Ribavirin Received | Up to Week 96 | Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period. |
| Secondary | Duration of Peginterferon Alfa-2a Therapy | Up to Week 72 | Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented. |
| Secondary | Percentage of Participants With the Most Frequent Concomitant Medications | At Baseline (Day 1) | Most frequent concomitant medications were defined as those, which were observed in \>1 % of participants. |
Source ClinicalTrials.gov
Outcomes9
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 Rapid Virologic Response (RVR) | At Week 4 | Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Early Virologic Response (EVR) | At Week 12 | Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With End of Treatment (EOT) Response | Up to Week 72 | Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Virologic Response (SVR) | Up to Week 96 | Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Drug Reactions (SADR) | Up to Week 96 | Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis. | percentage of participants | NUMBER |
| SECONDARY | Percentage Cumulative Dose of Peginterferon Alfa-2a Received | Up to Week 96 | Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis. | percentage of cumulated dose | MEDIAN |
| SECONDARY | Percentage Cumulative Dose of Ribavirin Received | Up to Week 96 | Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis. | percentage of cumulated dose | MEDIAN |
| SECONDARY | Duration of Peginterferon Alfa-2a Therapy | Up to Week 72 | Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With the Most Frequent Concomitant Medications | At Baseline (Day 1) | Only main analysis set had evaluable data for this outcome measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
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 Rapid Virologic Response (RVR) | Main Analysis Set | 40.0 | percentage of participants | ||
| Percentage of Participants With Rapid Virologic Response (RVR) | Elastography Analysis Set: Treated | 41.7 | percentage of participants | ||
| Percentage of Participants With Early Virologic Response (EVR) | Main Analysis Set | 71.2 | percentage of participants | ||
| Percentage of Participants With Early Virologic Response (EVR) | Elastography Analysis Set: Treated | 77.8 | percentage of participants | ||
| Percentage of Participants With End of Treatment (EOT) Response | Main Analysis Set | 59.2 | percentage of participants | ||
| Percentage of Participants With End of Treatment (EOT) Response | Elastography Analysis Set: Treated | 51.1 | percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response (SVR) | Main Analysis Set | 41.4 | percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response (SVR) | Elastography Analysis Set: Treated | 36.7 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Drug Reactions (SADR) | Main Analysis Set | 3.5 | percentage of participants | ||
| Percentage of Participants With Serious Adverse Drug Reactions (SADR) | Elastography Analysis Set: Treated | 3.3 | percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Main Analysis Set | 9,620 | |
| Overall Study | STARTED | Elastography Analysis Set: Treated | 90 | |
| Overall Study | STARTED | Elastography Analysis Set: Untreated | 518 | |
| Overall Study | COMPLETED | Main Analysis Set | 7,071 | |
| Overall Study | COMPLETED | Elastography Analysis Set: Treated | 50 | |
| Overall Study | COMPLETED | Elastography Analysis Set: Untreated | 518 | |
| Overall Study | NOT COMPLETED | Main Analysis Set | 2,549 | |
| Overall Study | NOT COMPLETED | Elastography Analysis Set: Treated | 40 | |
| Overall Study | NOT COMPLETED | Elastography Analysis Set: Untreated | 0 |
Source ClinicalTrials.gov
Adverse events996
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 | Anaemia | Blood and lymphatic system disorders | Main Analysis Set | 471 | 9,620 | |
| other | Anaemia | Blood and lymphatic system disorders | Elastography Analysis Set: Treated | 37 | 90 | |
| other | Anaemia | Blood and lymphatic system disorders | Elastography Analysis Set: Untreated | 0 | 518 | |
| other | Leukopenia | Blood and lymphatic system disorders | Main Analysis Set | 311 | 9,620 | |
| other | Leukopenia | Blood and lymphatic system disorders | Elastography Analysis Set: Treated | 30 | 90 | |
| other | Leukopenia | Blood and lymphatic system disorders | Elastography Analysis Set: Untreated | 0 | 518 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Main Analysis Set | 299 | 9,620 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Elastography Analysis Set: Treated | 31 | 90 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Elastography Analysis Set: Untreated | 0 | 518 | |
| other | Abdominal pain | Gastrointestinal disorders | Main Analysis Set | 187 | 9,620 |
1 to 10 of 996Source ClinicalTrials.gov
See all 996 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Main Analysis Set | ||
| Total, all-cause mortality | Elastography Analysis Set: Treated | ||
| Total, all-cause mortality | Elastography Analysis Set: Untreated | ||
| Total, other adverse events | Main Analysis Set | 5,721 | 9,620 |
| Total, other adverse events | Elastography Analysis Set: Treated | 82 | 90 |
| Total, other adverse events | Elastography Analysis Set: Untreated | 0 | 518 |
| Total, serious adverse events | Main Analysis Set | 439 | 9,620 |
| Total, serious adverse events | Elastography Analysis Set: Treated | 4 | 90 |
| Total, serious adverse events | Elastography Analysis Set: Untreated | 0 | 518 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25238535 | 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
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/NCT02106156
GET https://conductscience.org/api/trials/v1/NCT02106156/results?page=2