Adults with acute hepatitis C virus (HCV) infection MedDRA version: 20.1 Level: PT Classification code 10065051 Term: Acute hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Epclusa® 400 mg/100 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SOFOSBUVIR
CAS Number: 1190307-88-0
Other descriptive name: SOFOSBUVIR
Concentration unit:
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male or female, age > 18 years 3. HCV RNA > 103 IU/mL at screening 4. Confirmation of acute HCV infection documented by either: a. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening b. Documented conversion to HCV RNA positivity within the 4 months preceding screening c. or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 months preceding screening without evidence of confounding liver disorders 5. Body mass index (BMI) >18 kg/m2 6. Subjects must have the following laboratory parameters at screening: a. INR 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight) 7. 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 FU: • intrauterine device (IUD) with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Subject has been treated with any investigational drug or device within 42 days of the Screening visit or within 5 half-lives for investigational drugs, whichever is longer 2. Co-Infection with HIV 3. 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. 4. Solid organ transplantation 5. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis). 6. Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage). 7. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. 8. 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. 9. Significant drug allergy (such as anaphylaxis or hepatotoxicity). 10. Pregnant or nursing female 11. 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. 12. Clinical relevant(not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson’s disease, alpha1 antitrypsin deficiency, cholangitis) 13. 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 14. Known hypersensitivity to SOF/VEL or formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy (SVR 12);Secondary Objective: • To evaluate the HCV RNA kinetics during treatment and after stop of therapy measured as mean viral load at baseline, week 2, 4, 8 (EOT) and 12 weeks after stop of therapy. • To determine ALT normalization (ALT <ULN) after 8 weeks (EOT) of therapy and 12 weeks after stop of therapy (FU 12) Assessment of safety: Adverse events (AEs) will be collected throughout the study (up to 12 weeks after discontinuation of therapy, FU12). ;Primary end point(s): Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy (SVR 12);Timepoint(s) of evaluation of this end point: 12 weeks after discontinuation of therapy (SVR 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy • Proportion of subjects who reached ALT normalization (ALT <ULN) after 8 weeks of therapy (EOT) and 12 weeks after discontinuation of therapy (FU12) Assessment of safety: All adverse events will be collected throughout the study. Adverse events will be reported with absolute and relative frequencies for the whole study population. ;Timepoint(s) of evaluation of this end point: • at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy • after 8 weeks of therapy (EOT) and 12 weeks after discontinuation of therapy (FU12) • from baseline (informed consent)until the 12 weeks post-treatment visit. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Markus Cornberg
Hannover Medical School
Outcome results
None listed