Triple Combination DAAs for Treating HCV GT1b Subjects

NCT ID: NCT02932293

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOF+DCV+SMV 3-4 wks

Patients without cirrhosis will receive sofosbuvir, daclatasvir and simeprevir for (a) 3 weeks if HCV viral load on day 2 is \<500 IU/ml or (b) 4 weeks if HCV viral load on day 2 is \>500 IU/ml.

Group Type: EXPERIMENTAL

SOF+DCV+SMV

Intervention Type: DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

SOF+DCV+SMV 6-8 wks

Patients with cirrhosis and CP-A will receive sofosbuvir, daclatasvir and simeprevir (a) 6 weeks if HCV VL on day 2 is \<500 IU/ml or (b) 8 weeks if HCV VL on day 2 is \>500 IU/ml.

Group Type: EXPERIMENTAL

SOF+DCV+SMV

Intervention Type: DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

Interventions

SOF+DCV+SMV

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Beijing 302 Hospital

OTHER

Sponsor Role: collaborator

Humanity and Health Research Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George LAU, MD

Role: PRINCIPAL_INVESTIGATOR

Humanity & Health Medical Centre

Locations

Humanity and Health Medical Centre

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

H&H_SODAPI II

Identifier Type: -

Identifier Source: org_study_id