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Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics (SD100)

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ClinicalTrials.gov Identifier: NCT02596880
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Shahin Merat, Tehran University of Medical Sciences

Brief Summary:
The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Condition or disease Intervention/treatment Phase
Hepatitis C Cirrhosis Drug: Sofosbuvir Drug: Daclatasvir Drug: Ribavirin Phase 3

Detailed Description:
Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin
Study Start Date : September 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Treatment
Subjects will receive sofosbuvir, daclatasvir and ribavirin
Drug: Sofosbuvir
400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir
Other Name: Sovodak

Drug: Daclatasvir
60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir
Other Name: Sovodak

Drug: Ribavirin
1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
Other Name: RBV




Primary Outcome Measures :
  1. The sustained viral response rate [ Time Frame: week 24 (12 weeks after end of treatment) ]
    Qualitative HCV RNA polymerase chain reaction (PCR)


Secondary Outcome Measures :
  1. Adverse drug events [ Time Frame: week 2, 4, 8, 12, 24 ]
    Questionnaire



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive qualitative HCV RNA test on two occasions at least 6 months apart
  • Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity > 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria:

  • Renal failure (eGFR < 30 cc/min),
  • MELD score > 20,
  • Child's C (CTP score > 12),
  • Heart rate < 50/min,
  • Taking amiodarone

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): NCT02596880


Locations
Iran, Islamic Republic of
Shariati Hospital
Tehran, Iran, Islamic Republic of, 14117
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Reza Malekzadeh, M.D. Tehran University of Medical Sciences

Responsible Party: Shahin Merat, Professor of Gastroenterology and Hepatology, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02596880     History of Changes
Other Study ID Numbers: 94-02-159-30278
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shahin Merat, Tehran University of Medical Sciences:
Hepatitis C
Cirrhosis
Sofosbuvir
Daclatasvir
Ribavirin

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents