Trial · NCT02786537
Study of Oral Treatments for Hepatitis C
NCT02786537, Phase 4, Completed, University of Florida; results first posted 2020-11-24
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Oral Treatments for Hepatitis C. Trials, record NCT02786537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02786537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Oral Treatments for Hepatitis C
- NCT number
- NCT02786537
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,275 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Chronic Hepatitis C
- Interventions
- SOF/LDV (sofosbuvir/ledipasvir), PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only), EBR/GZR (elbasvir/grazoprevir), Ribavirin
- First posted
- 2016-06-01
- Last updated
- 2021-12-06
- Results first posted
- 2020-11-24
- Limitations and caveats
This pragmatic trial allowed patients who were randomized to SOF/LDV but unable to obtain SOF/LDV (due to limitations in access from insurance, etc.) to be treated with the accessible, alternative DAA regimens. This contributed to the variance from 'as randomized' population to the 'as treated' population. Rapidly changing HCV landscape led to discontinuation of PrOD treatment regimen and modification of initial analysis plan including reduction of original sample size.
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | 12 weeks post-treatment | SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider). mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2. |
| Primary | Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | 12-24 weeks post HCV treatment | SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2. |
| Primary | Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation | 12 weeks post-treatment | SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only. |
| Primary | Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | 12 -24 weeks post-treatment | SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). Number of subjects reflects participants randomized during Phase 1 only. |
| Primary | Mean Change in Headache-PRO Scores -Phase 1 | Baseline to On-Treatment | Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom. |
| Primary | Mean Change in Headache-EBR/GZR and SOF/LDV | Baseline to On-Treatment | Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD |
| Primary | Median Change in Headache -Phase 1 | 12 weeks (Baseline and Average On-treatment Score) | Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD |
| Primary | Median Change in Headache-Phase 2 | Baseline -on Treatment (12-16 weeks) | Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD |
| Primary | Mean Change in Nausea/Vomiting PRO Score -Phase 1 | Baseline to On-Treatment | Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement. The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status. |
| Primary | Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF | Baseline and Average On-Treatment Score | Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting. Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment. A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | 12 weeks post-treatment | mITT with imputation, Missing SVR data = Failure. Numbers represent participants according to arm randomized (Period 1). Population excludes participants who did not start any HCV treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | 12-24 weeks post HCV treatment | All mITT without imputation (missing data excluded). Includes only number of participants for whom SVR12 data is available and based on study drug as randomized (Period 1). Participants for whom SVR 12 is not available are excluded from this table. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation | 12 weeks post-treatment | mITT with imputation, Missing SVR data =failure. Numbers represent participants according to arm randomized (period 1). Population excludes participants who did not start any HCV treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | 12 -24 weeks post-treatment | Participants analyzed based on HCV treatment as assigned by randomization. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Change in Headache-PRO Scores -Phase 1 | Baseline to On-Treatment | Analysis limited to patients who completed a baseline and on-treatment PRO and as treated (Period 2) during Phase 1 only. | units on a scale | MEAN |
| PRIMARY | Mean Change in Headache-EBR/GZR and SOF/LDV | Baseline to On-Treatment | Analysis limited to participants who completed both baseline and end of treatment PRO | units on a scale | MEAN |
| PRIMARY | Median Change in Headache -Phase 1 | 12 weeks (Baseline and Average On-treatment Score) | Analysis limited to patients randomized up to last patient randomized to PrOD and participants who completed baseline and on-treatment survey. | units on a scale | MEDIAN |
| PRIMARY | Median Change in Headache-Phase 2 | Baseline -on Treatment (12-16 weeks) | Analysis limited to patients randomized to EBR/GZR regimen or SOF/LDV regimen and participants who completed both baseline and on treatment survey. | units on a scale | MEDIAN |
| PRIMARY | Mean Change in Nausea/Vomiting PRO Score -Phase 1 | Baseline to On-Treatment | Analysis is limited to patients who completed at least one baseline and one end of treatment PRO survey during Phase 1 (end date corresponds to last PrOD patient start date) | units on a scale | MEAN |
| PRIMARY | Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF | Baseline and Average On-Treatment Score | Patients with Baseline PROMIS Nausea/vomiting score who started treatment by arm as treated and completed baseline and on-treatment survey. | units on a scale | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group137
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | EBR/GZR With RBV | 40 | Participants | ||
| Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | EBR/GZR | 516 | Participants | ||
| Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | SOF/LDV With RBV | 14 | Participants | ||
| Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV | SOF/LDV | 335 | Participants | ||
| Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | EBR/GZR With RBV | 40 | Participants | ||
| Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | EBR/GZR | 516 | Participants | ||
| Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | SOF/LDV With RBV | 14 | Participants | ||
| Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) | SOF/LDV | 335 | Participants | ||
| Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation | EBR/GZR With RBV | 9 | Participants | ||
| Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation | EBR/GZR | 108 | Participants |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| As Randomized | STARTED | EBR/GZR With RBV | 56 | |
| As Randomized | STARTED | EBR/GZR | 644 | |
| As Randomized | STARTED | SOF/LDV With RBV | 15 | |
| As Randomized | STARTED | SOF/LDV | 413 | |
| As Randomized | STARTED | PrOD/RBV(Phase 1 Only) | 99 | |
| As Randomized | STARTED | PrOD (Phase 1 Only) | 48 | |
| As Randomized | COMPLETED | EBR/GZR With RBV | 50 | |
| As Randomized | COMPLETED | EBR/GZR | 582 | |
| As Randomized | COMPLETED | SOF/LDV With RBV | 15 | |
| As Randomized | COMPLETED | SOF/LDV | 378 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events456
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 | EBR/GZR | 2 | 664 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | EBR/GZR With RBV | 17 | 56 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | SOF/LDV With RBV | 2 | 15 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | SOF/LDV | 0 | 394 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | PrOD With RBV | 20 | 99 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | PrOD | 0 | 47 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | EBR/GZR | 7 | 664 | 7 |
| other | Abdominal discomfort | Gastrointestinal disorders | EBR/GZR With RBV | 1 | 56 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | SOF/LDV With RBV | 1 | 15 | 1 |
| other | Abdominal discomfort | Gastrointestinal disorders | SOF/LDV | 2 | 394 | 2 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EBR/GZR | 6 | 664 |
| Total, all-cause mortality | EBR/GZR With RBV | 0 | 56 |
| Total, all-cause mortality | SOF/LDV With RBV | 0 | 15 |
| Total, all-cause mortality | SOF/LDV | 4 | 394 |
| Total, all-cause mortality | PrOD With RBV | 1 | 99 |
| Total, all-cause mortality | PrOD | 0 | 47 |
| Total, other adverse events | EBR/GZR | 298 | 664 |
| Total, other adverse events | EBR/GZR With RBV | 46 | 56 |
| Total, other adverse events | SOF/LDV With RBV | 8 | 15 |
| Total, other adverse events | SOF/LDV | 184 | 394 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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 |
|---|
| EBR/GZR Regimen vs SOF/LDV Regimen: Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF |
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/NCT02786537
GET https://conductscience.org/api/trials/v1/NCT02786537/registered?page=2