Treatment of Hepatitis CPhase 2NCT02480387
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 study testing Ledipasvir/Sofosbuvir FDC in people with Treatment of Hepatitis C, run by Peter J. Ruane, M.D., Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Hepatitis C
- What is being tested?
- Ledipasvir/Sofosbuvir FDC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036
About this study
Official title: A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
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
- Conditions
- Treatment of Hepatitis C
- Being tested
- Ledipasvir/Sofosbuvir FDC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ledipasvir/Sofosbuvir FDCDrug
Also called Harvoni
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 8 weeks treatment with Ledipasvir/Sofosbuvir FDC Receives: Drug: Ledipasvir/Sofosbuvir FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Measured: Sustained Virologic Response 12 Weeks Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter J. Ruane, M.D., Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480387
- Sponsor's protocol ID
- IN-US-337-1821
- Status last verified
- Feb 2016
- First submitted
- 19 Jun 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
- ClinicalTrials.gov ID
- NCT02480387
- Acronym / sponsor ID
- IN-US-337-1821
- Conditions
- Treatment of Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peter J. Ruane, M.D., Inc.University, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Ledipasvir/Sofosbuvir FDC8 weeks treatment with Ledipasvir/Sofosbuvir FDC |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ledipasvir/Sofosbuvir FDCAlso: Harvoni | Drug | Treatment Arm |
Primary outcome
SVR12
Time frame: Sustained Virologic Response 12 Weeks Post-Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ledipasvir/Sofosbuvir FDC in people with Treatment of Hepatitis C, run by Peter J. Ruane, M.D., Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 (time frame: Sustained Virologic Response 12 Weeks Post-Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.