NCT02480387

Brief Summary

Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA \< 6 x106 IU/mL Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 20, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

June 19, 2015

Last Update Submit

July 19, 2016

Conditions

Treatment of Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • SVR12

    Sustained Virologic Response 12 Weeks Post-Treatment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

8 weeks treatment with Ledipasvir/Sofosbuvir FDC

Drug: Ledipasvir/Sofosbuvir FDC

Interventions

Ledipasvir/Sofosbuvir FDCDRUG
Also known as: Harvoni
Treatment Arm

Eligibility Criteria

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

You may qualify if:

  • Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects.
  • HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening

You may not qualify if:

  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
  • Solid organ transplantation.
  • Significant cardiac disease or other significant co-morbidities that could interfere with study treatment.
  • Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible.
  • Infection with hepatitis B virus (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

Interventions

ledipasvirledipasvir, sofosbuvir drug combination

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

June 24, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

July 20, 2016

Record last verified: 2016-02

Locations

US(1)