Trial · NCT01704755
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
NCT01704755, Phase 3, Completed, AbbVie (prior sponsor, Abbott); results first posted 2015-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis. Trials, record NCT01704755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
- NCT number
- NCT01704755
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 381 participants, actual
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Conditions
- Chronic Hepatitis C Infection, Compensated Cirrhosis
- Interventions
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- First posted
- 2012-10-11
- Last updated
- 2021-07-12
- Other registries' IDs
- eudract:2012-003088-23
- Results first posted
- 2015-01-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment | 12 weeks after the last actual dose of study drug | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug. |
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm | 12 weeks after the last actual dose of study drug | A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study drug. |
| Secondary | Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period | Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment). |
| Secondary | Percentage of Participants With Virologic Relapse After Treatment | within 12 weeks after the last dose of study drug | Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment. |
Source ClinicalTrials.gov
Outcomes4
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 Virologic Response 12 Weeks Post-treatment | 12 weeks after the last actual dose of study drug | All randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm | 12 weeks after the last actual dose of study drug | All randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period | Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24 | All randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Relapse After Treatment | within 12 weeks after the last dose of study drug | All randomized participants who received at least 1 dose of study drug with HCV RNA \< LLOQ at the final treatment visit who completed treatment. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
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 Virologic Response 12 Weeks Post-treatment | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 91.8 | Percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 96.5 | Percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 91.8 | Percentage of participants | ||
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 96.5 | Percentage of participants | ||
| Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 0.5 | 95% Confidence Interval 0.0 to 1.4 | Percentage of participants | |
| Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 1.7 | 95% Confidence Interval 0.0 to 3.7 | Percentage of participants | |
| Percentage of Participants With Virologic Relapse After Treatment | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 5.9 | 95% Confidence Interval 2.7 to 9.2 | Percentage of participants | |
| Percentage of Participants With Virologic Relapse After Treatment | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 0.6 | 95% Confidence Interval 0.0 to 1.8 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 208 | |
| Overall Study | STARTED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 172 | |
| Overall Study | Completed Study Drug | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 204 | |
| Overall Study | Completed Study Drug | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 163 | |
| Overall Study | COMPLETED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 196 | |
| Overall Study | COMPLETED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 165 | |
| Overall Study | NOT COMPLETED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 12 | |
| Overall Study | NOT COMPLETED | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 7 |
Source ClinicalTrials.gov
Adverse events130
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 | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 15 | 208 | |
| other | ANAEMIA | Blood and lymphatic system disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 17 | 172 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 6 | 208 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 9 | 172 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 11 | 208 | |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 16 | 172 | |
| other | DIARRHOEA | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 30 | 208 | |
| other | DIARRHOEA | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 29 | 172 | |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 7 | 208 | |
| other | GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 10 | 172 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | ||
| Total, all-cause mortality | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | ||
| Total, other adverse events | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 175 | 208 |
| Total, other adverse events | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 146 | 172 |
| Total, serious adverse events | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks | 13 | 208 |
| Total, serious adverse events | ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks | 7 | 172 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks vs ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks: serious adverse events |
Source Trial comparisons
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/NCT01704755
GET https://conductscience.org/api/trials/v1/NCT01704755/events?page=2