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Status unknownNCT02691728Updated Feb 25, 2016

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

A Phase 4 interventional study of LDV/SOF FDC in Chronic Hepatitis C, sponsored by Peter J. Ruane, M.D., Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Peter J. Ruane, M.D., Inc. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's planned enrollment of 40 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Peter J. Ruane, M.D., Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Infection with HIV or HBV
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treatment Arm

    12 Week treatment with LDV/SOF FDC

    Drug: LDV/SOF FDC

Interventions

  • DrugLDV/SOF FDC
06

What researchers measure

Primary outcomes

  1. SVR12 (Sustained Virologic Response)

    Time frame: Sustained Virologic Response 12 Weeks after Treatment Completion

07

Study locations

1 site
  • Peter J. Ruane, MD, Inc.
    Los Angeles, California 90036, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02691728
Lead sponsor
Peter J. Ruane, M.D., Inc.
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Feb 25, 2016
Start date
Feb 2016
Primary completion
Feb 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Feb 25, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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

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