Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03818308
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
HepNet Study House, German Liverfoundation
Gilead Sciences
German Center for Infection Research
Information provided by (Responsible Party):
Hannover Medical School

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 virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Acute Hepatitis C Drug: Sofosbuvir and Velpatasvir Phase 2

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 subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, single-arm multicenter, phase II pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Sofosbuvir and Velpatasvir
SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks
Drug: Sofosbuvir and Velpatasvir
All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.
Other Name: Epclusa 400 mg/100 mg film-coated tablets




Primary Outcome Measures :
  1. Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy [ Time Frame: 12 weeks after discontinuation of therapy ]
    Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)


Secondary Outcome Measures :
  1. Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy [ Time Frame: at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy ]
    Measured by mean HCV RNA viral load

  2. Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy [ Time Frame: after 8 weeks of therapy, and 12 weeks after discontinuation of therapy ]
    Measured by the proportion of subjects who reached ALT normalization (ALT < ULN)

  3. Assessment of frequency and severity of adverse events (AEs) [ Time Frame: through study completion, an average of 20 weeks ]
    Collection of all AEs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Male or female, age > 18 years
  3. HCV RNA > 10^3 IU/mL at screening
  4. Confirmation of acute HCV infection documented by either:

    1. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
    2. Documented conversion to HCV RNA positivity within the 4 months preceding screening
    3. 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
  5. Body mass index (BMI) ≥18 kg/m2
  6. Subjects must have the following laboratory parameters at screening:

    1. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    2. HbA1c ≤ 10%
    3. Creatinine clearance (CLcr) ≥ 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 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
  8. 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 Criteria:

  1. Subject has been treated with any investigational drug or device within 42 days of the Screening visit
  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, α1 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818308


Contacts
Layout table for location contacts
Contact: Markus Cornberg, Prof. Dr. +49511532 ext 6821 cornberg.markus@mh-hannover.de
Contact: Julia Kahlhöfer, Dr. +49 511 532 ext 6817 kahlhoefer.julia@mh-hannover.de

Locations
Layout table for location information
Germany
Allgemeinmedizinische und internistische Praxis Recruiting
Berlin-Friedrichshain, Germany, 10243
Contact: Christiane Cordes, Dr.    +493097002288    studien@praxiswarschauer33.de   
Principal Investigator: Christiane Cordes, Dr.         
Zentrum für Infektiologie Prenzlauer Berg Recruiting
Berlin, Germany, 10349
Contact: Patrick Ingiliz, Dr.    0049 30 451988 ext 9415    studienzentrum@zibp.de   
Principal Investigator: Patrick Ingiliz, Dr.         
Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie Recruiting
Berlin, Germany, 13353
Contact: Tobias Müller, PD Dr.    0049 30 45056 ext 5207    tobias.mueller@charite.de   
Principal Investigator: Tobias Müller, PD Dr.         
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I Recruiting
Bonn, Germany, 53127
Contact: Robert Hüneburg, Dr.    0049 228 2871 ext 5260    hepa.studienambulanz@ukbonn.de   
Principal Investigator: Robert Hüneburg, Dr.         
Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie Recruiting
Essen, Germany, 45122
Contact: Gudrun Hilgard, Dr.    0049 201 723 ext 3610    gudrun.hilgard@uk-essen.de   
Principal Investigator: Gudrun Hilgard, Dr.         
Klinikum der J.W. Goethe-Universität Frankfurt Not yet recruiting
Frankfurt, Germany, 60590
Contact: Stefan Zeuzem, Prof. Dr.    0049 69 6301 ext 6204    zeuzem@em.uni-frankfurt.de   
Principal Investigator: Stefan Zeuzem, Prof. Dr.         
Infektionsmedizinisches Centrum Hamburg (ICH) Study Center Recruiting
Hamburg, Germany, 20146
Contact: Hans-Jürgen Stellbrink, Prof. Dr.    0049 40 2840 ext 7370    mail@ich-studycenter.com   
Principal Investigator: Hans-Jürgen Stellbrink, Prof. Dr.         
Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik Recruiting
Hamburg, Germany, 20246
Contact: Julian Schulze zur Wiesch, PD Dr.    0049 40 74105 ext 7981    v.schlicker@uke.de   
Principal Investigator: Julian Schulze zur Wiesch, PD Dr.         
Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie Recruiting
Hannover, Germany, 30625
Contact: Markus Cornberg, Prof. Dr.    0049 511 532 ext 6821    cornberg.markus@mh-hannover.de   
Principal Investigator: Marcus Cornberg, Prof. Dr.         
Praxis Hohenstaufenring Recruiting
Köln, Germany, 50674
Contact: Stefan Scholten, Dr.    0049 221 35505 ext 450    studien@phsr.de   
Principal Investigator: Stefan Scholten, Dr.         
Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie Recruiting
Leipzig, Germany, 04103
Contact: Johannes Wiegand, Prof. Dr.    0049 341 971 ext 2330    johannes.wiegand@medizin.uni-leipzig.de   
Principal Investigator: Johannes Wiegand, Prof. Dr.         
Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik Recruiting
München, Germany, 81675
Contact: Christoph Spinner, PD Dr.    0049 89 4140 ext 5236    christoph.spinner@mri.tum.de   
Principal Investigator: Christoph Spinner, PD Dr.         
Gemeinschaftspraxis - Infectomed Recruiting
Stuttgart, Germany, 70197
Contact: Daniel Egetemeyr, Dr.    0049 711 6155 ext 320    praxis@schwabstrasse59.de   
Principal Investigator: Daniel Egetemeyr, Dr.         
Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie Recruiting
Würzburg, Germany, 97080
Contact: Hartwig Klinker, Prof. Dr.    0049 931 2014 ext 0043    klinker_h@ukw.de   
Principal Investigator: Hartwig Klinker, Prof. Dr.         
Sponsors and Collaborators
Hannover Medical School
HepNet Study House, German Liverfoundation
Gilead Sciences
German Center for Infection Research
Investigators
Layout table for investigator information
Principal Investigator: Markus Cornberg, Prof. Dr. Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Layout table for additonal information
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03818308    
Other Study ID Numbers: HepNet-aHCV-V
2018-003474-27 ( EudraCT Number )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hannover Medical School:
Acute hepatitis C virus (HCV) infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Velpatasvir
Antiviral Agents
Anti-Infective Agents