Trials / Unknown
UnknownNCT03037151
Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV
Safety and Fibrosis Improvement of Grazoprevir and Elbasvir for HCV GT1 and GT6 With or Without HIV
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of combination treatment with grazoprevir + elbasvir for compensated cirrhotic participants with chronic genotype 1 (GT1) and genotype 6 (GT6) hepatitis C virus (HCV) infection with or without human immunodeficiency virus (HIV) infection.
Detailed description
Total 100 patients with compensated cirrhosis, chronically infected with HCV GT1 or GT6 with or without HIV infection will be included. Patients with HCV GT1 and GT6 will be enrolled on a 1:1 basis (approximately 50 patients with GT1 and 50 patients with GT6). Treatment-naïve patients will be treated with the combination of grazoprevir plus elbasvir for 12 weeks. Treatment-experienced patients, including null responders, partial responders or post-treatment relapsers, will be assigned to treat with the combination plus weight-based RBV for 16 weeks. The dosages of study drugs are 100 mg of grazoprevir once daily and 50 mg of elbasvir once daily. All patients will follow up to assess SVR (defined by HCV RNA level \<12 IU/mL) at week12 and week 24 after treatment (SVR12 and SVR24, respectively). Additionally, participants will be evaluated the longitudinal changes in LS values by TE up to 240 weeks (5 years) after treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Grazaoprevir/Elbasavir | treatment naive |
| DRUG | Grazaoprevir/Elbasavir/RBV | treatment experienced |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2017-01-31
- Last updated
- 2020-02-13
Locations
2 sites across 1 country: Thailand
Source: ClinicalTrials.gov record NCT03037151. Inclusion in this directory is not an endorsement.