NCT02691728

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 22, 2016

Last Update Submit

February 24, 2016

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • SVR12 (Sustained Virologic Response)

    Sustained Virologic Response 12 Weeks after Treatment Completion

Study Arms (1)

Treatment Arm

EXPERIMENTAL

12 Week treatment with LDV/SOF FDC

Drug: LDV/SOF FDC

Interventions

LDV/SOF FDCDRUG
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Infection with HIV or HBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter J. Ruane, MD, Inc.

Los Angeles, California, 90036, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

May 1, 2017

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

US(1)