Trial · NCT01318694
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
NCT01318694, Phase 3, Completed, Debiopharm International SA; results first posted 2016-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants. Trials, record NCT01318694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01318694
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
- NCT number
- NCT01318694
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,081 participants, actual
- Lead sponsor
- Debiopharm International SA
- Conditions
- Hepatitis C
- Interventions
- Alisporivir, Peginterferon alfa-2a, Ribavirin, ALV Placebo
- First posted
- 2011-03-18
- Last updated
- 2016-09-30
- Other registries' IDs
- eudract:2010-022867-37
- Results first posted
- 2016-09-30
- Limitations and caveats
- In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | 12 weeks after the end of treatment | SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment. |
| Secondary | Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | 24 weeks after the end of treatment | SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment. |
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) | after 4 weeks of treatment | RVR4 was defined as serum HCV RNA \< LOQ after 4 weeks of treatment. |
| Secondary | Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment | after 12 weeks of treatment | EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \< LOQ after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | cEVR was defined as serum HCV RNA \< LOQ after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment | from 4 to 12 weeks of treatment | eRVR was defined as achieving RVR4 and maintaining HCV RNA \< LOQ until Week 12. |
| Secondary | Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks | at treatment end within 48 weeks | ETR was defined as serum HCV RNA \< LOQ at treatment end (completed or prematurely discontinued). |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks | within 48 weeks | ALT abnormalities were summarized as participants who had either: * ALT \> 2 x upper limit of normal (ULN) during the study and \> 2 x ULN at baseline * ALT \> 3 x ULN during the study and \> 2 x ULN at baseline |
| Secondary | Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks | within 48 weeks | Grading was according to the Modified Division of Microbiology \& Infectious Diseases (DMID) Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | 12 weeks after the end of treatment | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | 24 weeks after the end of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) | after 4 weeks of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment | after 12 weeks of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment | from 4 to 12 weeks of treatment | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks | at treatment end within 48 weeks | Participants in the Full Analysis Set with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks | within 48 weeks | Participants in the Safety Set, defined as having received at least one dose of study medication, with available data | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks | within 48 weeks | Participants in the Safety Set with available data | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | Treatment Arm A | 68.6 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | Treatment Arm B | 68.9 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | Treatment Arm C | 69.4 | percentage of participants | ||
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | Treatment Arm D | 52.5 | percentage of participants | ||
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | Treatment Arm A | 68.5 | percentage of participants | ||
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | Treatment Arm B | 69.0 | percentage of participants | ||
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | Treatment Arm C | 68.3 | percentage of participants | ||
| Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | Treatment Arm D | 51.7 | percentage of participants | ||
| Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) | Treatment Arm A | 60.1 | percentage of participants | ||
| Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) | Treatment Arm B | 72.5 | percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm A | 275 | |
| Overall Study | STARTED | Treatment Arm B | 270 | |
| Overall Study | STARTED | Treatment Arm C | 268 | |
| Overall Study | STARTED | Treatment Arm D | 268 | |
| Overall Study | Full Analysis Set | Treatment Arm A | 274 | |
| Overall Study | Full Analysis Set | Treatment Arm B | 270 | |
| Overall Study | Full Analysis Set | Treatment Arm C | 265 | |
| Overall Study | Full Analysis Set | Treatment Arm D | 268 | |
| Overall Study | Safety Set | Treatment Arm A | 273 | |
| Overall Study | Safety Set | Treatment Arm B | 268 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events624
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 | Treatment Arm A | 113 | 273 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Arm B | 124 | 268 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Arm C | 91 | 265 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment Arm D | 88 | 265 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm A | 48 | 273 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm B | 27 | 268 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm C | 48 | 265 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment Arm D | 27 | 265 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment Arm A | 15 | 273 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment Arm B | 7 | 268 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm A | ||
| Total, all-cause mortality | Treatment Arm B | ||
| Total, all-cause mortality | Treatment Arm C | ||
| Total, all-cause mortality | Treatment Arm D | ||
| Total, other adverse events | Treatment Arm A | 256 | 273 |
| Total, other adverse events | Treatment Arm B | 261 | 268 |
| Total, other adverse events | Treatment Arm C | 250 | 265 |
| Total, other adverse events | Treatment Arm D | 242 | 265 |
| Total, serious adverse events | Treatment Arm A | 24 | 273 |
| Total, serious adverse events | Treatment Arm B | 28 | 268 |
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/NCT01318694
GET https://conductscience.org/api/trials/v1/NCT01318694/results?page=2