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Trial record 47 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

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ClinicalTrials.gov Identifier: NCT02576314
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

Brief Summary:
The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: sofosbuvir and daclatasvir Drug: ledipasvir/sofosbuvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection
Study Start Date : May 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sofosbuvir and Daclatasvir
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
Drug: sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Other Names:
  • Sovaldi®
  • PSI-7977
  • GS-7977
  • Daklinza®
  • BMS-790052

Active Comparator: Ledipasvir/sofosbuvir
Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
Drug: ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.

once daily;

Other Names:
  • Harvoni®
  • GS-5885
  • GS-7977
  • PSI-7977




Primary Outcome Measures :
  1. Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy [ Time Frame: Post treatment Week 12 ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication

  2. Incidence of adverse events leading to permanent discontinuation of study drug [ Time Frame: Baseline up to Week 12 ]

Secondary Outcome Measures :
  1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 12 ]
  2. HCV RNA levels and change during and after treatment [ Time Frame: Baseline up to Week 12 ]
  3. Treatment adherence [ Time Frame: Baseline to Week 12 ]
    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

  4. Change in health related quality of life [ Time Frame: Baseline to Week 24 ]
    To evaluate the change in health-related quality of life during treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
  • Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  • HCV RNA > 10,000 IU/mL at Screening;
  • Screening laboratory values within defined thresholds;
  • Negative pregnancy test at baseline (females of childbearing potential only);
  • Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

  • Pregnant or nursing female;
  • HIV infection or HBV infection (HBcAb and HBsAg positive);
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576314


Locations
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China, Beijing
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing, China, 100039
China, Hong Kong
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China, 00852
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
Investigators
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Principal Investigator: George Lau, MD Humanity and Health GI and Liver Centre

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Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02576314     History of Changes
Other Study ID Numbers: H&H_HCV G3 Study
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Infection
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents