Status:
COMPLETED
Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
HepNet Study House, German Liverfoundation
Gilead Sciences
Conditions:
Hepatitis C
Acute Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C viru...
Detailed Description
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the proportion of subject...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- Male or female, age \> 18 years
- HCV RNA \> 10\^3 IU/mL at screening
- Confirmation of acute HCV infection documented by either:
- Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
- Documented conversion to HCV RNA positivity within the 4 months preceding screening
- or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 month preceding screening without evidence of confounding liver disorders
- Body mass index (BMI) ≥18 kg/m2
- Subjects must have the following laboratory parameters at screening:
- INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
- HbA1c ≤ 10%
- Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
- A negative serum pregnancy test is required for female subjects (unless surgically sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
- Or
- Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of follow up:
- intrauterine device (IUD) with a failure rate of \< 1% per year
- female barrier method: cervical cap or diaphragm with spermicidal agent
- tubal sterilization
- vasectomy in male partner
- hormone-containing contraceptive:
- implants of levonorgestrel
- injectable progesterone
- oral contraceptives (either combined or progesterone only)
- contraceptive vaginal ring
- transdermal contraceptive patch
- Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments
Exclusion
- Subject has been treated with any investigational drug or device within 42 days of the Screening visit
- Co-Infection with HIV
- Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
- Solid organ transplantation
- Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
- Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included.
- Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Pregnant or nursing female
- Clinically-relevant drug or alcohol abuse that significantly impairs patient compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
- Clinical relevant (not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
- Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1 visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end of treatment;
- Known hypersensitivity to SOF/VEL or formulation excipients
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03818308
Start Date
May 28 2019
End Date
June 8 2021
Last Update
July 6 2021
Active Locations (14)
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1
Zentrum für Infektiologie Prenzlauer Berg
Berlin, Germany, 10349
2
Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Berlin, Germany, 13353
3
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
Bonn, Germany, 53127
4
Praxis Hohenstaufenring
Cologne, Germany, 50674