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Trial record 73 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 (SL50)

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ClinicalTrials.gov Identifier: NCT02705534
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Bakhtar Bioshimi Co
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 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: Ledipasvir Drug: Ribavirin Phase 3

Detailed Description:
Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/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/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Subjects will receive sofosbuvir, ledipasvir and ribavirin
Drug: Sofosbuvir
400 mg, included in a combination pill with 90 mg ledipasvir
Other Name: SOF

Drug: Ledipasvir
90 mg, included in a combination pill with 400 mg sofosbuvir
Other Name: LDV

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 polymerase chain reaction assay for Hepatitis C RNA


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 hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion Criteria:

  • Renal failure [estimated glomerular filtration rate (eGFR) < 30 cc/min],
  • Model or End stage Liver Disease (MELD) score > 20,
  • Child's class C (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): NCT02705534


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
Bakhtar Bioshimi Co
Investigators
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Study Chair: Reza Malekzadeh, M.D. Tehran University of Medical Sciences

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02705534     History of Changes
Other Study ID Numbers: 94-04-37-31023
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tehran University of Medical Sciences:
Hepatitis C
Cirrhosis
Sofosbuvir
Ledipasvir
Ribavirin
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis A
Hepatitis C
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents