Trial · NCT02219490
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT02219490, Phase 3, Completed, AbbVie; results first posted 2023-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection. Trials, record NCT02219490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02219490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
- NCT number
- NCT02219490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,596 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Chronic Hepatitis C Virus (HCV) Infection Genotype 1
- Interventions
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- First posted
- 2014-08-19
- Last updated
- 2023-04-07
- Other registries' IDs
- eudract:2014-001022-14
- Results first posted
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-Cause Death: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Primary | Liver-Related Death: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Primary | Liver Decompensation: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Primary | Liver Transplantation: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Primary | Hepatocellular Carcinoma: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945). |
| Primary | All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945. |
| Secondary | Change From Baseline in FibroScan Score by SVR12 Status | At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260 | The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis. |
| Secondary | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last actual dose of study drug | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-Cause Death: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | Liver-Related Death: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | Liver Decompensation: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | Liver Transplantation: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | Hepatocellular Carcinoma: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| PRIMARY | All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event | At Post-Treatment Weeks 52, 104, 156, 208, and 260 | Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in FibroScan Score by SVR12 Status | At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260 | ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data | kPa | MEAN |
| SECONDARY | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | 12 weeks after the last actual dose of study drug | ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Kaplan-Meier estimate at PT Week 52 | 8.3 | 95% Confidence Interval 3.1 to 21.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 | Kaplan-Meier estimate at PT Week 52 | 0.1 | 95% Confidence Interval 0.1 to 0.4 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Kaplan-Meier estimate at PT Week 104 | 8.3 | 95% Confidence Interval 3.1 to 21.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 | Kaplan-Meier estimate at PT Week 104 | 0.7 | 95% Confidence Interval 0.4 to 1.1 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Kaplan-Meier estimate at PT Week 156 | 8.3 | 95% Confidence Interval 3.1 to 21.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 | Kaplan-Meier estimate at PT Week 156 | 1.2 | 95% Confidence Interval 0.8 to 1.8 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Kaplan-Meier estimate at PT Week 208 | 8.3 | 95% Confidence Interval 3.1 to 21.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 | Kaplan-Meier estimate at PT Week 208 | 1.5 | 95% Confidence Interval 1.1 to 2.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12 | Kaplan-Meier estimate at PT Week 260 | 8.3 | 95% Confidence Interval 3.1 to 21.2 | percentage of participants |
| All-Cause Death: Time to Event | Participants in Studies M14-222 and M14-423 Who Achieved SVR12 | Kaplan-Meier estimate at PT Week 260 | 2.0 | 95% Confidence Interval 1.5 to 2.8 | percentage of participants |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow3
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 Plus ABT-333 With or Without Ribavirin (RBV) | 1,596 | |
| Overall Study | COMPLETED | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 1,258 | |
| Overall Study | NOT COMPLETED | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 338 |
Source ClinicalTrials.gov
Adverse events61
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 | DIARRHOEA | Gastrointestinal disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 103 | 1,596 | 112 |
| other | NAUSEA | Gastrointestinal disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 186 | 1,596 | 200 |
| other | ASTHENIA | General disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 165 | 1,596 | 179 |
| other | FATIGUE | General disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 300 | 1,596 | 331 |
| other | HEADACHE | Nervous system disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 291 | 1,596 | 319 |
| other | INSOMNIA | Psychiatric disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 179 | 1,596 | 183 |
| other | PRURITUS | Skin and subcutaneous tissue disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 199 | 1,596 | 209 |
| serious | ANAEMIA | Blood and lymphatic system disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 1 | 1,596 | 1 |
| serious | ANGINA UNSTABLE | Cardiac disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 1 | 1,596 | 1 |
| serious | PALPITATIONS | Cardiac disorders | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 1 | 1,596 | 1 |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 28 | 1,596 |
| Total, other adverse events | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 805 | 1,596 |
| Total, serious adverse events | ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV) | 40 | 1,596 |
Source ClinicalTrials.gov
Papers0
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/NCT02219490
GET https://conductscience.org/api/trials/v1/NCT02219490/results?page=2