Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir (NCT03818308) | Clinical Trial Compass
CompletedPhase 2
Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
Germany20 participantsStarted 2019-05-28
Plain-language 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 virus (HCV) infection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
Timeframe: 12 weeks after discontinuation of therapy
. 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.