Triple Combination DAAs for Treating HCV GT1b Subjects

Chronic Hepatitis C Infection Clinical Trial

Official title:

Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02932293
• Other study ID #: H&H_SODAPI II
• Status: Withdrawn
• Phase: Phase 2
• First received: October 5, 2016
• Last updated: May 11, 2017
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Humanity & Healthy GI and Liver Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Hong Kong	Humanity and Health Medical Centre	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
Humanity & Healthy GI and Liver Centre	Beijing 302 Hospital, Emory University, University of Maryland

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.	Post treatment Week 12
Secondary	Frequency and severity of adverse events		Baseline up to Week 24
Secondary	Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment		Baseline up to Week 24
Secondary	Kinetics of circulating HCV RNA during treatment and after treatment discontinuation		Baseline up to Week 24
Secondary	Proportion of participants with on-treatment virologic breakthrough and relapse	Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR up to 24 weeks.	Baseline up to Week 24