Triple Combination DAAs for Treating HCV GT1b Subjects

NCT02932293 | Withdrawn Phase 2 DMC

• 1 other identifier: H&H_SODAPI II
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency and severity of adverse events

  Baseline up to Week 24

• Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

  Baseline up to Week 24

• Kinetics of circulating HCV RNA during treatment and after treatment discontinuation

  Baseline up to Week 24

• Proportion of participants with on-treatment virologic breakthrough and relapse

  Baseline up to Week 24

Study Arms (2)

SOF+DCV+SMV 3-4 wks

EXPERIMENTAL

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.

Drug: SOF+DCV+SMV

SOF+DCV+SMV 6-8 wks

EXPERIMENTAL

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.

Drug: SOF+DCV+SMV

Interventions

SOF+DCV+SMV 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 3-4 wks; SOF+DCV+SMV 6-8 wks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV RNA positive \>2000 IU/ml or NAT POC positive
• Genotype 1b
• CP score ≤6

You may not qualify if:

• Pregnant or nursing female or male with pregnant female partner
• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
• Active or recent history (≤ 1 year) of drug or alcohol abuse
• Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
• 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.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• University of Maryland: collaborator
• Emory University: collaborator
• Beijing 302 Hospital: collaborator

Study Sites (1)

Humanity and Health Medical Centre

Hong Kong, 00852, Hong Kong

Location

Study Officials

• George LAU, MD

  Humanity & Health Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 13, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 12, 2017

Record last verified: 2016-10

Locations

HK (1)