A Phase 3 interventional study of Boceprevir in Hepatitis C, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-21.
Sponsored by University of Calgary · Phase 3, Interventional, and Treatment
The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).
i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response.
ii) Evaluate adverse events. iii) Evaluate viral resistance.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 11 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be eligible for the study if they meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from participation in this study if the following conditions are present:
Drug: Boceprevir
All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
Also known as: VICTRELIS™, boceprevir capsules, 200 mg, Hepatitis C Virus (HCV) Protease Inhibitor
Sustained Virologic Response (SVR) at 24 Weeks Post Treatment
Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
Time frame: 24 weeks after treatment
It was hoped that 21 patients with chronic HCV genotype 3 who had failed to achieve an SVR with a standard course of treatment with Peginterferon α + ribavirin (PR) would be selected from the University of Calgary Liver Unit (UCLU) database. 11 patients were able to be enrolled in the study.The last patient completed the study in December 2014.
| Milestone | Victrelis Triple |
|---|---|
| Started | 10 |
| Completed | 6 |
| Not completed | 4 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 2 |
Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.
| participants | Victrelis Triple |
|---|---|
| Subjects who completed treatment | 6 |
| Subjects who obtained SVR 24 | 3 |
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Victrelis Triple | — | 2/10 (20%) | 10/10 (100%) |
| Event | Victrelis Triple |
|---|---|
| Emergency room visit due to suspected celulitisInfections and infestations | 1/10 |
| Pregnancy in spouseReproductive system and breast disorders | 1/10 |
| Event | Victrelis Triple |
|---|---|
| InsomniaGeneral disorders | 10/10 |
| AnemiaBlood and lymphatic system disorders | 9/10 |
| Local injection site reactionsSkin and subcutaneous tissue disorders | 9/10 |
| Muscle painMusculoskeletal and connective tissue disorders | 9/10 |
| ChillsGeneral disorders | 8/10 |
| DysgeusiaGastrointestinal disorders | 8/10 |
| FatigueGeneral disorders | 8/10 |
| LeukopeniaBlood and lymphatic system disorders | 8/10 |
| NeutropeniaBlood and lymphatic system disorders | 8/10 |
| ThrombocytopeniaBlood and lymphatic system disorders | 8/10 |
| Age, Categorical(Participants) | Victrelis Triple |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Age, Continuous(years) | Victrelis Triple |
|---|---|
| Mean | 53.3 ± 6.945 |
| Sex: Female, Male(Participants) | Victrelis Triple |
|---|---|
| Female | 0 |
| Male | 10 |
| Region of Enrollment(participants) | Victrelis Triple |
|---|---|
| Canada | 10 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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University of Calgary