Trial · NCT01741545
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
NCT01741545, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia. Trials, record NCT01741545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01741545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
- NCT number
- NCT01741545
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 71 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatitis C Virus
- Interventions
- Pegylated-Interferon-lambda, Ribavirin, Daclatasvir
- First posted
- 2012-12-05
- Last updated
- 2020-08-11
- Other registries' IDs
- eudract:2012-003463-22
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 | Follow-up Week 12 | SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. |
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) | Treatment Week 4 | RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4. |
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) | Treatment Week 12 | cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12. |
| Secondary | Percentage of Participants With End of the Treatment Response (EOTR) | End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B) | EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment. |
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) | Follow-up Week 24 | SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. |
| Secondary | Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment | After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) \<10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) \<750 mm\^3, and/or thrombocytopenia: platelets \<50,000 mm\^3. |
| Secondary | Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment | After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain. |
| Secondary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death | From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B) | AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug. |
| Secondary | Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities | After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): \>2.0\*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : \>5\*ULN; Aspartate aminotransferase (AST): \>5\*ULN; Prothrombin Time (PT): \>1.50\*ULN; Bilirubin (Total): \>2.5\*ULN; Triglycerides (fasting): \>750 mg/dL. |
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 | Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 | Follow-up Week 12 | The analysis was performed in modified intent to treat (mITT) population defined as participants meeting the response criteria over all treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rapid Virologic Response (RVR) | Treatment Week 4 | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Early Virologic Response (cEVR) | Treatment Week 12 | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With End of the Treatment Response (EOTR) | End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B) | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) | Follow-up Week 24 | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment | After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment | After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | mITT population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death | From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B) | All treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities | After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B) | All treated participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 | Cohort A | 91.7 | 95% Confidence Interval 61.5 to 99.8 | Percentage of participants | |
| Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12 | Cohort B | 89.7 | 95% Confidence Interval 75.8 to 97.1 | Percentage of participants | |
| Percentage of Participants With Rapid Virologic Response (RVR) | Cohort A | 91.7 | 95% Confidence Interval 61.5 to 99.8 | Percentage of participants | |
| Percentage of Participants With Rapid Virologic Response (RVR) | Cohort B | 76.9 | 95% Confidence Interval 60.7 to 88.9 | Percentage of participants | |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Cohort A | 91.7 | 95% Confidence Interval 61.5 to 99.8 | Percentage of participants | |
| Percentage of Participants With Complete Early Virologic Response (cEVR) | Cohort B | 92.3 | 95% Confidence Interval 79.1 to 98.4 | Percentage of participants | |
| Percentage of Participants With End of the Treatment Response (EOTR) | Cohort A | 100 | 95% Confidence Interval 73.5 to 100 | Percentage of participants | |
| Percentage of Participants With End of the Treatment Response (EOTR) | Cohort B | 100 | 95% Confidence Interval 91 to 100 | Percentage of participants | |
| Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) | Cohort A | 66.7 | 95% Confidence Interval 34.9 to 90.1 | Percentage of participants | |
| Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24) | Cohort B | 30.8 | 95% Confidence Interval 17 to 47.6 | Percentage of participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Cohort A | 12 | |
| Treatment Period | STARTED | Cohort B | 39 | |
| Treatment Period | COMPLETED | Cohort A | 11 | |
| Treatment Period | COMPLETED | Cohort B | 35 | |
| Treatment Period | NOT COMPLETED | Cohort A | 1 | |
| Treatment Period | NOT COMPLETED | Cohort B | 4 | |
| Follow-up Period (24 Weeks) | STARTED | Cohort A | 12 | |
| Follow-up Period (24 Weeks) | STARTED | Cohort B | 39 | |
| Follow-up Period (24 Weeks) | COMPLETED | Cohort A | 11 | |
| Follow-up Period (24 Weeks) | COMPLETED | Cohort B | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events94
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 | Haematoma | Vascular disorders | Cohort A | 0 | 12 | 0 |
| other | Haematoma | Vascular disorders | Cohort B | 3 | 39 | 3 |
| other | Haemorrhage | Vascular disorders | Cohort A | 0 | 12 | 0 |
| other | Haemorrhage | Vascular disorders | Cohort B | 2 | 39 | 2 |
| other | Asthenia | General disorders | Cohort A | 0 | 12 | 0 |
| other | Asthenia | General disorders | Cohort B | 12 | 39 | 12 |
| other | Fatigue | General disorders | Cohort A | 3 | 12 | 3 |
| other | Fatigue | General disorders | Cohort B | 9 | 39 | 9 |
| other | Pyrexia | General disorders | Cohort A | 1 | 12 | 1 |
| other | Pyrexia | General disorders | Cohort B | 5 | 39 | 5 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 0 | 12 |
| Total, all-cause mortality | Cohort B | 0 | 39 |
| Total, other adverse events | Cohort A | 10 | 12 |
| Total, other adverse events | Cohort B | 36 | 39 |
| Total, serious adverse events | Cohort A | 0 | 12 |
| Total, serious adverse events | Cohort B | 4 | 39 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A vs Cohort B: deaths from any cause | Trial comparisons |
| Cohort A vs Cohort B: 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/NCT01741545
GET https://conductscience.org/api/trials/v1/NCT01741545/results?page=2