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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

P

Peter J. Ruane, M.D., Inc.

Status and phase

Unknown
Phase 4

Conditions

Chronic Hepatitis C

Treatments

Drug: LDV/SOF FDC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02691728
IN_US-337-1748

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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