Triple Combination DAAs for Treating HCV GT1b Subjects

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Humanity & Healthy GI and Liver Centre; Humanity and Health Research Centre
• Collaborators: Beijing 302 Hospital; Emory University; University of Maryland; University of Maryland, College Park
• Treatments: Simeprevir; Sofosbuvir

Criteria

Inclusion Criteria:

1. HCV RNA positive >2000 IU/ml or NAT POC positive

2. Genotype 1b

3. CP score ≤6

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner

2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements

3. Active or recent history (≤ 1 year) of drug or alcohol abuse

4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)

5. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.