Trial · NCT01728324
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
NCT01728324, Phase 3, Completed, Boehringer Ingelheim; results first posted 2016-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2. Trials, record NCT01728324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01728324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
- NCT number
- NCT01728324
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 496 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Hepatitis C, Chronic
- Interventions
BI 207127-placebo: 8-week treatment, Ribavirin: 24-week treatment, BI 207127: 24-week treatment, Faldaprevir: 24-week treatment, Faldaprevir: 24-week treatment, Ribavirin-placebo: 8-week treatment, BI 207127: 24-week treatment, Faldaprevir-placebo: 8-week treatment, Faldaprevir: 16-week treatment, Ribavirin: 16-week treatment, RBV: 24-week treatment, BI 207127: 16-week treatment
- First posted
- 2012-11-19
- Last updated
- 2016-02-12
- Other registries' IDs
- eudract:2012-003535-27
- Results first posted
- 2016-02-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SVR12 Rates With Historical Control | 12 Week (post-treatment) | Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level \<25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed. |
| Primary | Comparisons of SVR12 Rates Across Treatment Arms | 12 Week (post-treatment) | Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint. |
| Secondary | SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | 4 weeks (after End Of Treatment) | Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level \<25 IU/mL at 4 weeks after EOT. |
| Secondary | SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. | 4 weeks (after End Of Treatment) | Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level \<25 IU/mL at 24 weeks after EOT. |
| Secondary | Prognostic Value of SVR12 Predicting SVR24 | 24 Week (post-treatment) | The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SVR12 Rates With Historical Control | 12 Week (post-treatment) | Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment; | percentage of participants | NUMBER |
| PRIMARY | Comparisons of SVR12 Rates Across Treatment Arms | 12 Week (post-treatment) | FAS | Percentage of participants | NUMBER |
| SECONDARY | SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | 4 weeks (after End Of Treatment) | FAS | percentage of participants | NUMBER |
| SECONDARY | SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT. | 4 weeks (after End Of Treatment) | FAS | percentage of participants | NUMBER |
| SECONDARY | Prognostic Value of SVR12 Predicting SVR24 | 24 Week (post-treatment) | FAS | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SVR12 Rates With Historical Control | 24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group | PegIFN eligible | 79.95 | percentage of participants | |
| SVR12 Rates With Historical Control | 16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group | PegIFN eligible | 76.68 | percentage of participants | |
| SVR12 Rates With Historical Control | 24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group | PegIFN ineligible | 88.28 | percentage of participants | |
| SVR12 Rates With Historical Control | 16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group | PegIFN ineligible | 70.78 | percentage of participants | |
| Comparisons of SVR12 Rates Across Treatment Arms | 24-wk Non-cirrhotic (NC) Treatment Group | 82.0 | 95% Confidence Interval 76.8 to 87.2 | Percentage of participants | |
| Comparisons of SVR12 Rates Across Treatment Arms | 16-wk Non-cirrhotic (NC) Treatment Group | 75.6 | 95% Confidence Interval 69.8 to 81.4 | Percentage of participants | |
| Comparisons of SVR12 Rates Across Treatment Arms | 24-wk Cirrhotic (CR) Treatment Group | 73.6 | 95% Confidence Interval 63.4 to 83.8 | Percentage of participants | |
| SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | 24-wk Non-cirrhotic (NC) Treatment Group | 83.9 | 95% Confidence Interval 78.9 to 88.8 | percentage of participants | |
| SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | 16-wk Non-cirrhotic (NC) Treatment Group | 80.3 | 95% Confidence Interval 74.9 to 85.6 | percentage of participants | |
| SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT. | 24-wk Cirrhotic (CR) Treatment Group | 77.8 | 95% Confidence Interval 68.2 to 87.4 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Termination of DBV | STARTED | 24-wk Non-cirrhotic (NC) Treatment Group | 211 | |
| Termination of DBV | STARTED | 16-wk Non-cirrhotic (NC) Treatment Group | 213 | |
| Termination of DBV | STARTED | 24-wk Cirrhotic (CR) Treatment Group | 72 | |
| Termination of DBV | COMPLETED | 24-wk Non-cirrhotic (NC) Treatment Group | 173 | |
| Termination of DBV | COMPLETED | 16-wk Non-cirrhotic (NC) Treatment Group | 177 | |
| Termination of DBV | COMPLETED | 24-wk Cirrhotic (CR) Treatment Group | 58 | |
| Termination of DBV | NOT COMPLETED | 24-wk Non-cirrhotic (NC) Treatment Group | 38 | |
| Termination of DBV | NOT COMPLETED | 16-wk Non-cirrhotic (NC) Treatment Group | 36 | |
| Termination of DBV | NOT COMPLETED | 24-wk Cirrhotic (CR) Treatment Group | 14 | |
| Termination of FDV | STARTED | 24-wk Non-cirrhotic (NC) Treatment Group | 211 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events228
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 | 24-wk Non-cirrhotic (NC) Treatment Group | 26 | 211 | |
| other | Anaemia | Blood and lymphatic system disorders | 16-wk Non-cirrhotic (NC) Treatment Group | 22 | 213 | |
| other | Anaemia | Blood and lymphatic system disorders | 24-wk Cirrhotic (CR) Treatment Group | 13 | 72 | |
| other | Vertigo | Ear and labyrinth disorders | 24-wk Non-cirrhotic (NC) Treatment Group | 8 | 211 | |
| other | Vertigo | Ear and labyrinth disorders | 16-wk Non-cirrhotic (NC) Treatment Group | 6 | 213 | |
| other | Vertigo | Ear and labyrinth disorders | 24-wk Cirrhotic (CR) Treatment Group | 5 | 72 | |
| other | Ocular icterus | Eye disorders | 24-wk Non-cirrhotic (NC) Treatment Group | 27 | 211 | |
| other | Ocular icterus | Eye disorders | 16-wk Non-cirrhotic (NC) Treatment Group | 16 | 213 | |
| other | Ocular icterus | Eye disorders | 24-wk Cirrhotic (CR) Treatment Group | 2 | 72 | |
| other | Abdominal distension | Gastrointestinal disorders | 24-wk Non-cirrhotic (NC) Treatment Group | 6 | 211 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 24-wk Non-cirrhotic (NC) Treatment Group | ||
| Total, all-cause mortality | 16-wk Non-cirrhotic (NC) Treatment Group | ||
| Total, all-cause mortality | 24-wk Cirrhotic (CR) Treatment Group | ||
| Total, other adverse events | 24-wk Non-cirrhotic (NC) Treatment Group | 198 | 211 |
| Total, other adverse events | 16-wk Non-cirrhotic (NC) Treatment Group | 202 | 213 |
| Total, other adverse events | 24-wk Cirrhotic (CR) Treatment Group | 66 | 72 |
| Total, serious adverse events | 24-wk Non-cirrhotic (NC) Treatment Group | 7 | 211 |
| Total, serious adverse events | 16-wk Non-cirrhotic (NC) Treatment Group | 12 | 213 |
| Total, serious adverse events | 24-wk Cirrhotic (CR) Treatment Group | 8 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27920566 | 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/NCT01728324
GET https://conductscience.org/api/trials/v1/NCT01728324/flow?page=2