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Trial record 16 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients (HepCC-2)

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: NCT03061032
Recruitment Status : Unknown
Verified February 2017 by Iran Hepatitis Network.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Information provided by (Responsible Party):
Iran Hepatitis Network

Brief Summary:
Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir/Ledipasvir 12W Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W Drug: Sofosbuvir/Ledipasvir 24W Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sofosbuvir/Ledipasvir for 12W

Patients without cirrhosis and previous history of treatment will be treated with this regimen.

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

Drug: Sofosbuvir/Ledipasvir 12W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.

Experimental: Sofosbuvir/Ledipasvir+Ribavirin for 12W

Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen.

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.

Experimental: Sofosbuvir/Ledipasvir for 24W

Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen.

Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

Drug: Sofosbuvir/Ledipasvir 24W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.

Experimental: Sofosbuvir/Ledipasvir+Ribavirin for 24W
Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.




Primary Outcome Measures :
  1. Sustained Virologic Response [ Time Frame: 12 weeks after completion of treatment ]
    Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection



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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:

  • Chronic HCV infection
  • >18 years old

Exclusion Criteria:

  • HIV co-infected
  • Liver transplanted
  • Receiving drugs with suspected interactions

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): NCT03061032


Contacts
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Contact: Seyed Moayed Alavian, MD +989121073195 alavian@thc.ir
Contact: Heidar Sharafi, PhD +989125176030 h.sharafi@meldcenter.com

Sponsors and Collaborators
Iran Hepatitis Network
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Investigators
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Study Chair: Seyed Moayed Alavian, MD Iran Hepatitis Network
Study Director: Heidar Sharafi, PhD Iran Hepatitis Network
Principal Investigator: Bita Behnava, MD Iran Hepatitis Network
Principal Investigator: Mohammad Saeid Rezaee-Zavareh, MD Iran Hepatitis Network

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Responsible Party: Iran Hepatitis Network
ClinicalTrials.gov Identifier: NCT03061032     History of Changes
Other Study ID Numbers: IHN10002
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents