Trial · NCT03117569
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
NCT03117569, Phase 3, Completed, Kirby Institute; results first posted 2019-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients. Trials, record NCT03117569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03117569
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
- NCT number
- NCT03117569
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 380 participants, actual
- Lead sponsor
- Kirby Institute
- Conditions
- Hepatitis C, Chronic
- Interventions
- glecaprevir (300mg)/pibrentasvir (120mg)
- First posted
- 2017-04-18
- Last updated
- 2019-12-11
- Results first posted
- 2019-12-11
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Undetectable HCV RNA (ITT Population) | 12 weeks post end of treatment (SVR12) | Number of participants with undetectable HCV RNA based on ITT population. |
| Secondary | Undetectable HCV RNA (mITT Population) | 12 weeks post end of treatment (SVR12) | Number of participants with undetectable HCV RNA based on mITT population. |
| Secondary | Treatment and Study Visits Adherence | 12 weeks post end of treatment (SVR12) | Number adherent to treatment and study visits (on-treatment adherence and early treatment discontinuation). |
| Secondary | Health-related Quality of Life | Screening and 12 weeks post end of treatment (SVR12) | Change in health-related quality of life score pre and post-treatment (measured by EQ-5D-3L). The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (value of 100) and 'Worst imaginable health state' (value of 0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. Higher scores indicate better outcomes. |
| Secondary | Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12 | Baseline and 12 weeks post-treatment | Distribution of baseline resistance associated substitutions (RAS) in participants with virological failures. Baseline polymorphisms were detected by Sanger sequencing at the following amino acid positions: NS3: 36, 56, 80, 155, 156, 166, 168 NS5A: 24, 28, 30, 31, 58, 93 |
| Secondary | Patient Treatment Satisfaction | 12 weeks post end of treatment (SVR12) | Patient was satisfied with their treatment follow-up plan. |
| Other | Common Adverse Events (Safety Outcome) | 12 weeks post end of treatment (SVR12) | Proportion of patients with common adverse events (reported in greater than 5%). |
| Other | Severe/Life Threatening Adverse Events (Safety Outcome) | 12 weeks post end of treatment (SVR12) | Proportion of patients with at least one severe or potentially life threatening (grade 3 or 4) adverse event. |
| Other | Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome) | 12 weeks post end of treatment (SVR12) | Provider acceptability of simplified monitoring strategy measured by study specific questionnaire completed by each site Principal Investigator and the primary Research Nurse. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Undetectable HCV RNA (ITT Population) | 12 weeks post end of treatment (SVR12) | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Undetectable HCV RNA (mITT Population) | 12 weeks post end of treatment (SVR12) | The mITT population wexcludes patients who have completed treatment (\>95% adherence) (according to phone contact at week 8), but have not returned for their SVR12 assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment and Study Visits Adherence | 12 weeks post end of treatment (SVR12) | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Health-related Quality of Life | Screening and 12 weeks post end of treatment (SVR12) | score on a scale | MEDIAN | |
| SECONDARY | Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12 | Baseline and 12 weeks post-treatment | Number of participants in the ITT population with virological failure (detectable HCV RNA) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Treatment Satisfaction | 12 weeks post end of treatment (SVR12) | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Common Adverse Events (Safety Outcome) | 12 weeks post end of treatment (SVR12) | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Severe/Life Threatening Adverse Events (Safety Outcome) | 12 weeks post end of treatment (SVR12) | ITT | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome) | 12 weeks post end of treatment (SVR12) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Undetectable HCV RNA (ITT Population) | Standard Monitoring Schedule | 121 | Participants | ||
| Undetectable HCV RNA (ITT Population) | Simplified Monitoring Schedule | 233 | Participants | ||
| Undetectable HCV RNA (mITT Population) | Standard Monitoring Schedule | 121 | Participants | ||
| Undetectable HCV RNA (mITT Population) | Simplified Monitoring Schedule | 233 | Participants | ||
| Treatment and Study Visits Adherence | Standard Monitoring Schedule | >=95% Adherence | 125 | Participants | |
| Treatment and Study Visits Adherence | Simplified Monitoring Schedule | >=95% Adherence | 241 | Participants | |
| Treatment and Study Visits Adherence | Standard Monitoring Schedule | <95% Adherence | 2 | Participants | |
| Treatment and Study Visits Adherence | Simplified Monitoring Schedule | <95% Adherence | 12 | Participants | |
| Health-related Quality of Life | Standard Monitoring Schedule | Screening | 80 | Full Range 20 to 100 | score on a scale |
| Health-related Quality of Life | Simplified Monitoring Schedule | Screening | 80 | Full Range 40 to 100 | score on a scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Monitoring Schedule | 127 | |
| Overall Study | STARTED | Simplified Monitoring Schedule | 253 | |
| Overall Study | COMPLETED | Standard Monitoring Schedule | 123 | |
| Overall Study | COMPLETED | Simplified Monitoring Schedule | 241 | |
| Overall Study | NOT COMPLETED | Standard Monitoring Schedule | 4 | |
| Overall Study | NOT COMPLETED | Simplified Monitoring Schedule | 12 |
Source ClinicalTrials.gov
Adverse events12
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 | Fatigue | General disorders | Standard Monitoring Schedule | 30 | 127 | |
| other | Fatigue | General disorders | Simplified Monitoring Schedule | 52 | 253 | |
| other | Headache | Nervous system disorders | Standard Monitoring Schedule | 26 | 127 | |
| other | Headache | Nervous system disorders | Simplified Monitoring Schedule | 43 | 253 | |
| other | Nausea | Gastrointestinal disorders | Standard Monitoring Schedule | 25 | 127 | |
| other | Nausea | Gastrointestinal disorders | Simplified Monitoring Schedule | 17 | 253 | |
| serious | Leukocytosis | Blood and lymphatic system disorders | Standard Monitoring Schedule | 0 | 127 | 0 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Simplified Monitoring Schedule | 1 | 253 | 1 |
| serious | Acute psychosis | Psychiatric disorders | Standard Monitoring Schedule | 0 | 127 | 0 |
| serious | Acute psychosis | Psychiatric disorders | Simplified Monitoring Schedule | 1 | 253 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Monitoring Schedule | 0 | 127 |
| Total, all-cause mortality | Simplified Monitoring Schedule | 1 | 253 |
| Total, other adverse events | Standard Monitoring Schedule | 81 | 127 |
| Total, other adverse events | Simplified Monitoring Schedule | 112 | 253 |
| Total, serious adverse events | Standard Monitoring Schedule | 0 | 127 |
| Total, serious adverse events | Simplified Monitoring Schedule | 3 | 253 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31655134 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Monitoring Schedule vs Simplified Monitoring Schedule: Undetectable HCV RNA (mITT Population) | Trial comparisons |
| Standard Monitoring Schedule vs Simplified Monitoring Schedule: Severe/Life Threatening Adverse Events (Safety Outcome) | Trial comparisons |
| Standard Monitoring Schedule vs Simplified Monitoring Schedule: Undetectable HCV RNA (ITT Population) | Trial comparisons |
| Standard Monitoring Schedule vs Simplified Monitoring Schedule: deaths from any cause | Trial comparisons |
| Standard Monitoring Schedule vs Simplified Monitoring Schedule: serious adverse events | 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/NCT03117569
GET https://conductscience.org/api/trials/v1/NCT03117569/results?page=2