Trial · NCT02292706
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
NCT02292706, Terminated, Gilead Sciences; results first posted 2023-10-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection. Trials, record NCT02292706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02292706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- NCT number
- NCT02292706
- Status
- Terminated
- Enrollment
- 1,609 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Hepatitis C Virus Infection
- Interventions
- Sofosbuvir, Ribavirin, LDV/SOF, SOF/VEL, SOF/VEL/VOX, Other SOF-Based Regimen, Ineligible parent treatment
- First posted
- 2014-11-17
- Last updated
- 2023-10-04
- Other registries' IDs
- eudract:2014-001249-26
- Results first posted
- 2023-10-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | Week 240 | SVR at Week 240 was defined as HCV RNA\< lower limit of quantification (LLOQ i.e., 15 or 25 international units per milliliter \[IU/mL\]) or last available HCV RNA\< LLOQ with no subsequent follow-up values at Week 240 after enrollment in this registry study. Percentage of participants who maintained SVR status by Week 240 was estimated using a Kaplan-Meier model. |
| Primary | Percentage of Participants With Any Liver-Associated Events | Enrollment up to 240 weeks | The percentage of participants with any liver-associated events since registry start (enrollment) through Week 240 was estimated using a Kaplan-Meier model. |
| Primary | Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | Enrollment up to 240 weeks | Participants with de novo HCC since registry start were defined as participants who had not been identified with HCC prior to registry start and only had HCC since registry start. The percentage of participants who developed de novo HCC through Week 240 was estimated using a Kaplan-Meier model. |
| Secondary | Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 | Enrollment up to 240 weeks | |
| Secondary | Number of Participants With Detectable HCV Resistance Mutations Through Week 240 | Enrollment up to 240 weeks | |
| Secondary | Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | Enrollment up to 240 weeks | Reinfection was defined as HCV RNA \> LLOQ on 2 samples collected at least 1 week apart with a different virus than that present prior to treatment baseline in the parent study. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | Week 240 | Full Analysis Set included all participants who met all inclusion criteria and did not meet any of the exclusion criteria, and with at least one post-enrollment visit measurement available. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Any Liver-Associated Events | Enrollment up to 240 weeks | Participants in Full Analysis Set who did not develop liver-associated event prior to entering the registry were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Developed Hepatocellular Carcinoma (HCC) Through Week 240 | Enrollment up to 240 weeks | Participants in the Full Analysis Set with no HCC prior to this registry study were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Detectable HCV RNA Due to Re-emergence of Pre-existing Virus Through Week 240 | Enrollment up to 240 weeks | Participants in Full Analysis Set were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Detectable HCV Resistance Mutations Through Week 240 | Enrollment up to 240 weeks | Participants in Full Analysis Set were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Detectable HCV RNA Due to Re-infection Through Week 240 | Enrollment up to 240 weeks | Participants in Full Analysis Set were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SOF+RBV | 98.9 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | LDV/SOF | 100 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | LDV/SOF+RBV | 99.6 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SOF/VEL | 99.7 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SOF/VEL+RBV | 100 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | SOF/VEL/VOX | 99.6 | percentage of participants | ||
| Percentage of Participants Maintaining Sustained Virologic Response (SVR) at Week 240 | Other SOF-Based | 100 | percentage of participants | ||
| Percentage of Participants With Any Liver-Associated Events | SOF+RBV | 18.7 | percentage of participants | ||
| Percentage of Participants With Any Liver-Associated Events | LDV/SOF | 15.0 | percentage of participants | ||
| Percentage of Participants With Any Liver-Associated Events | LDV/SOF+RBV | 24.8 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SOF+RBV | 95 | |
| Overall Study | STARTED | LDV/SOF | 277 | |
| Overall Study | STARTED | LDV/SOF+RBV | 265 | |
| Overall Study | STARTED | SOF/VEL | 374 | |
| Overall Study | STARTED | SOF/VEL+RBV | 100 | |
| Overall Study | STARTED | SOF/VEL/VOX | 338 | |
| Overall Study | STARTED | Other SOF-Based | 141 | |
| Overall Study | STARTED | Enrolled From Ineligible Parent Treatment Group | 19 | |
| Overall Study | COMPLETED | SOF+RBV | 49 | |
| Overall Study | COMPLETED | LDV/SOF | 145 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events64
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 | Vessel puncture site haematoma | General disorders | SOF+RBV | 0 | 94 | |
| other | Vessel puncture site haematoma | General disorders | LDV/SOF | 2 | 275 | |
| other | Vessel puncture site haematoma | General disorders | LDV/SOF+RBV | 0 | 263 | |
| other | Vessel puncture site haematoma | General disorders | SOF/VEL | 0 | 372 | |
| other | Vessel puncture site haematoma | General disorders | SOF/VEL+RBV | 0 | 98 | |
| other | Vessel puncture site haematoma | General disorders | SOF/VEL/VOX | 0 | 332 | |
| other | Vessel puncture site haematoma | General disorders | Other SOF-Based | 1 | 139 | |
| other | Vessel puncture site haematoma | General disorders | Enrolled From Ineligible Parent Treatment Group | 0 | 0 | |
| other | Incision site rash | Injury, poisoning and procedural complications | SOF+RBV | 0 | 94 | |
| other | Incision site rash | Injury, poisoning and procedural complications | LDV/SOF | 0 | 275 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SOF+RBV | 3 | 95 |
| Total, all-cause mortality | LDV/SOF | 11 | 277 |
| Total, all-cause mortality | LDV/SOF+RBV | 16 | 265 |
| Total, all-cause mortality | SOF/VEL | 22 | 374 |
| Total, all-cause mortality | SOF/VEL+RBV | 8 | 100 |
| Total, all-cause mortality | SOF/VEL/VOX | 17 | 338 |
| Total, all-cause mortality | Other SOF-Based | 3 | 141 |
| Total, all-cause mortality | Enrolled From Ineligible Parent Treatment Group | 0 | 19 |
| Total, other adverse events | SOF+RBV | 0 | 94 |
| Total, other adverse events | LDV/SOF | 4 | 275 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
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 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/NCT02292706
GET https://conductscience.org/api/trials/v1/NCT02292706/results?page=2