Genotype 1 Hepatitis C VirusPhase 4NCT02759861
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
A Phase 4 study testing harvoni in people with Genotype 1 Hepatitis C Virus, run by University of Nebraska at 1 site in United States.
Trial summary
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Genotype 1 Hepatitis C Virus
- What is being tested?
- harvoni
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 1 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be willingly and able to provide written informed consent
- Age 19 years of age or older (The age of consent in Nebraska)
- HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
- HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
- HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
- Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
Show all 27Show fewer
- Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:
- Cirrhosis is defined as any one of the following:
- History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
- Fibroscan showing cirrhosis or results > 12.5 kPa
- FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
- Absence of cirrhosis is defined as any one of the following:
- Liver biopsy within 2 years of Screening showing absence of cirrhosis
- Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa
- FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening
- Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
- Subjects must have the following laboratory parameters at screening:
- ALT < 10 x the upper limit of normal (ULN)
- AST < 10 x ULN
- Direct bilirubin < 2.0 x ULN
- Platelets > 50,000
- HbA1c < 8.5%
- Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
- Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
- Albumin ≥ 2.5 g/dL
- INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
- Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
Who cannot join
- Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
- Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
- Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
- Known hypersensitivity to LDV/SOF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Read the detailed description
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
- Conditions
- Genotype 1 Hepatitis C Virus
- Being tested
- harvoni
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
harvoniDrug
Also called Ledipasvir/Sofosbuvir
8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
| Study group | Role | What they receive |
|---|---|---|
| Harvoni x 8 or 12 weeks | Experimental | patient will receive 8 or 12 weeks depending on clinical data Receives: Drug: harvoni |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Sustained viral response in treatment -naive heavy alcohol drinking patients.
Measured: 12 weeks after the end of Harvoni therapy
Secondary outcomes (1)
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR
Measured: 12 weeks after the end of Harvoni therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 Aug 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genotype 1 Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Mailliard, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759861
- Sponsor's protocol ID
- 0121-16-FB
- Status last verified
- Dec 2023
- First submitted
- 26 Apr 2016
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT02759861
- Acronym / sponsor ID
- 0121-16-FB
- Conditions
- Genotype 1 Hepatitis C Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 23 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Detailed description
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harvoni x 8 or 12 weeks | Experimental | Drug: harvonipatient will receive 8 or 12 weeks depending on clinical data |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- The subject must be willingly and able to provide written informed consent
- Age 19 years of age or older (The age of consent in Nebraska)
- HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
- HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
- HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
Key exclusion criteria (6 listed)
- Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
- Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
- Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
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 |
|---|---|---|
| harvoniAlso: Ledipasvir/Sofosbuvir8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy | Drug | Harvoni x 8 or 12 weeks |
Primary outcome
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Time frame: 12 weeks after the end of Harvoni therapy
Sustained viral response in treatment -naive heavy alcohol drinking patients.
1 secondary outcome
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Time frame: 12 weeks after the end of Harvoni therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mark Mailliard, MD principal investigator
UNMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing harvoni in people with Genotype 1 Hepatitis C Virus, run by University of Nebraska 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 27 inclusion and 6 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 29 Dec 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Subjects Who Achieve Negative RNA in Alcoholics (time frame: 12 weeks after the end of Harvoni therapy). 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 29 Dec 2023.