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Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

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ClinicalTrials.gov Identifier: NCT02691728
Recruitment Status : Unknown
Verified February 2016 by Peter J. Ruane, M.D., Inc..
Recruitment status was:  Not yet recruiting
First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Peter J. Ruane, M.D., Inc.

Brief Summary:
This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: LDV/SOF FDC Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Treatment Arm
12 Week treatment with LDV/SOF FDC
Drug: LDV/SOF FDC



Primary Outcome Measures :
  1. SVR12 (Sustained Virologic Response) [ Time Frame: Sustained Virologic Response 12 Weeks after Treatment Completion ]


Information from the National Library of Medicine

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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 GT1 or GT4 HCV Infection
  • Diagnosed with autoimmune disease (rheumatoid arthritis, psoriatic arthritis, lupus, etc.) and is currently receiving treatment for the condition.

Exclusion Criteria:

  • Infection with HIV or HBV

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): NCT02691728


Locations
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United States, California
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States, 90036
Sponsors and Collaborators
Peter J. Ruane, M.D., Inc.
Gilead Sciences

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Responsible Party: Peter J. Ruane, M.D., Inc.
ClinicalTrials.gov Identifier: NCT02691728     History of Changes
Other Study ID Numbers: IN_US-337-1748
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Autoimmune Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Immune System Diseases
Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents