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CompletedNCT02480387Updated Jul 20, 2016

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

A Phase 2 interventional study of Ledipasvir/Sofosbuvir FDC in Treatment of Hepatitis C, sponsored by Peter J. Ruane, M.D., Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by Peter J. Ruane, M.D., Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
01

Study 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

02

Conditions studied

  • Treatment of Hepatitis C
03

In context

Lead sponsor

Peter J. Ruane, M.D., Inc. is the lead sponsor of 3 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
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Treatment Arm

    8 weeks treatment with Ledipasvir/Sofosbuvir FDC

    Drug: Ledipasvir/Sofosbuvir FDC

Interventions

06

What researchers measure

Primary outcomes

  1. SVR12

    Time frame: Sustained Virologic Response 12 Weeks Post-Treatment

07

Study locations

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

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Nov 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2015
First posted
Jun 24, 2015
Start
May 2015
Primary completionActual
Nov 2015
CompletionActual
Jan 2016
Last update
Jul 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02480387
Lead sponsor
Peter J. Ruane, M.D., Inc.
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
May 2015
Primary completion
Nov 2015
Completion
Jan 2016
Last update
Jul 20, 2016

Oversight

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

Not currently enrolling

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

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Ledipasvir · Sofosbuvir

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

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