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Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir (SD-CRF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063879
Recruitment Status : Completed
First Posted : February 24, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborators:
Ahvaz Jundishapur University of Medical Sciences
Shiraz University of Medical Sciences
Hamadan University of Medical Science
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Chronic Renal Failure Drug: Sofosbuvir 400 mg and daclatasvir 60 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sovodak
Sofosbuvir 400 mg and daclatasvir 60 mg
Drug: Sofosbuvir 400 mg and daclatasvir 60 mg
Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic
Other Name: Sovodak




Primary Outcome Measures :
  1. Sustained Viral Response (SVR12) [ Time Frame: 12 weeks after end of treatment ]
    Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment


Secondary Outcome Measures :
  1. Safety as assessed by adverse drug events [ Time Frame: From start of treatment to 12 weeks after end of treatment ]
    Adverse drug events recorded by direct questioning



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
  • Renal failure (eGFR < 30 cc/min) or under hemodialysis

Exclusion Criteria:

  • Model for End-stage Liver Disease (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): NCT03063879


Locations
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Iran, Islamic Republic of
Shariati Hospital
Tehran, Iran, Islamic Republic of, 14117
Sponsors and Collaborators
Tehran University of Medical Sciences
Ahvaz Jundishapur University of Medical Sciences
Shiraz University of Medical Sciences
Hamadan University of Medical Science
Investigators
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Principal Investigator: Shahin Merat, MD Tehran University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03063879    
Other Study ID Numbers: 96-04-37-37348
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tehran University of Medical Sciences:
hepatitis C
renal failure
sofosbuvir
daclatasvir
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Renal Insufficiency
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Kidney Diseases
Urologic Diseases
Hepatitis, Chronic
Renal Insufficiency, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents