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Trial record 29 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

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ClinicalTrials.gov Identifier: NCT02309918
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
Hannover Medical School
Gilead Sciences
Information provided by (Responsible Party):
HepNet Study House, German Liverfoundation

Tracking Information
First Submitted Date  ICMJE November 4, 2014
First Posted Date  ICMJE December 5, 2014
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • Efficacy of treatment with ledipasvir (LDV)/sofosbuvir (SOF) FDC (proportion of subjects with sustained viral response (HCV RNA < LLOQ TND) using COBAS TaqMan Realtime PCR) [ Time Frame: 12 weeks ]
    To evaluate the efficacy of treatment with ledipasvir (LDV)/sofosbuvir (SOF) FDC for 6 weeks in patients with acute genotype 1 HCV infection as measured by the proportion of subjects with sustained viral response (HCV RNA < LLOQ TND) 12 weeks after discontinuation of therapy (SVR 12) using COBAS TaqMan Realtime PCR.
  • Safety and tolerability of LDV/SOF FDC-containing regimens (frequency of AEs and SAEs) [ Time Frame: 24 weeks after treatment ]
    To evaluate the safety and tolerability of LDV/SOF FDC-containing regimens administered for up to 6 weeks in patients with acute genotype 1 HCV infection as measured by the frequency of AEs and SAEs assessed at end of treatment, 12 and 24 weeks after end of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02309918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • Durability of response (proportion of subjects with sustained viral response (HCV RNA < LLOQ TND) [ Time Frame: 24 weeks after treatment ]
    To determine the durability of response after discontinuation of therapy as measured by the proportion of subjects with sustained viral response (HCV RNA < LLOQ TND) 24 weeks after discontinuation of therapy (SVR 24).
  • Kinetics of circulating HCV RNA (mean viral load) [ Time Frame: 24 weeks after treatment ]
    To evaluate the kinetics of circulating HCV RNA measured as mean viral load during treatment (Baseline, week 2,4,6) and after treatment discontinuation (Follow up week 4, 12, 24)
  • Emergence of viral resistance to LDV/SOF FDC [ Time Frame: 24 weeks after treatment ]
    To evaluate the emergence of viral resistance to LDV/SOF FDC during treatment and after treatment discontinuation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 4, 2014)
  • HCV-specific T cell responses [ Time Frame: 24 weeks after treatment ]
    To assess any relationship between HCV-specific T cell responses and treatment efficacy
  • Relationship between NK cell phenotype and function and treatment efficacy [ Time Frame: 24 weeks after treatment ]
    To assess any relationship between NK cell phenotype and function and treatment efficacy
  • Relationship between circulating serum chemokines and treatment efficacy and safety [ Time Frame: 24 weeks after treatment ]
    To assess any relationship between circulating serum chemokines and treatment efficacy and safety
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection
Official Title  ICMJE Interferon-free Treatment of Acute Genotype 1 Hepatitis C Virus Infection With Ledipasvir/Sofosbuvir Fixed-Dose Combination - The HepNet Acute HCV IV Study
Brief Summary This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Hepatitis C
Intervention  ICMJE Drug: LDV/SOF FDC
Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily
Study Arms  ICMJE LDV/SOF FDC
Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily
Intervention: Drug: LDV/SOF FDC
Publications * Deterding K, Spinner CD, Schott E, Welzel TM, Gerken G, Klinker H, Spengler U, Wiegand J, Schulze Zur Wiesch J, Pathil A, Cornberg M, Umgelter A, Zöllner C, Zeuzem S, Papkalla A, Weber K, Hardtke S, von der Leyen H, Koch A, von Witzendorff D, Manns MP, Wedemeyer H; HepNet Acute HCV IV Study Group. Ledipasvir plus sofosbuvir fixed-dose combination for 6 weeks in patients with acute hepatitis C virus genotype 1 monoinfection (HepNet Acute HCV IV): an open-label, single-arm, phase 2 study. Lancet Infect Dis. 2017 Feb;17(2):215-222. doi: 10.1016/S1473-3099(16)30408-X. Epub 2016 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 genotype 1 HCV infection documented by either:

    documented seroconversion to HCV antibody 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 weeks preceding screening without evidence of confounding liver disorders

  5. If the patient visits a physician due to symptoms of acute HCV, no greater than a 12 week interval may have elapsed between the time of the visit and screening
  6. Non-cirrhotic. Absence of cirrhosis will be determined based on clinical parameters or ultrasound
  7. Body mass index (BMI) ≥ 18 kg/m2
  8. Screening ECG without clinically significant abnormalities
  9. Subjects must have the following laboratory parameters at screening:

    1. Hemoglobin ≥ 10 g/dL
    2. Platelets ≥ 90,000/µL
    3. INR ≤1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    4. Albumin ≥ 3 g/dL
    5. HbA1c ≤ 10%
    6. Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft- Gault equation
  10. Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
  11. 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 30 days after last dose of study drug:

    • 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
  12. Male subjects must agree to refrain from sperm donation from the day of screening and for at least 90 days after the last dose of study drug.
  13. Subject must be of generally good health as determined by the Investigator.
  14. 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. 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; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
  2. Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
  3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  4. Clinical hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
  5. Solid organ transplantation.
  6. Significant pulmonary disease or significant cardiac disease.
  7. 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.
  8. Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
  9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
  10. Any prior treatment for HCV infection including prior exposure to any inhibitor of the NS5B and NS5A.
  11. Pregnant or nursing female or male with pregnant female partner
  12. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  13. Infection with hepatitis B virus (HBV; defined as HBsAg-positive) or human immunodeficiency virus (HIV)
  14. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
  15. Clinically-relevant drug or alcohol abuse within 12 months of screening including any uncontrolled drug use within 6 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
  16. Donation or loss of more than 400 ml blood within 2 months prior to Baseline/Day 1
  17. Use of any prohibited concomitant medications within 21 days of the Baseline/Day 1 visit, this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before Day 1.
  18. Known hypersensitivity to LDV, SOF or formulation excipients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02309918
Other Study ID Numbers  ICMJE HepNet-aHCV-IV
2013-001081-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party HepNet Study House, German Liverfoundation
Study Sponsor  ICMJE HepNet Study House, German Liverfoundation
Collaborators  ICMJE
  • Hannover Medical School
  • Gilead Sciences
Investigators  ICMJE
Principal Investigator: Michael P. Manns, Prof. Dr. MHH, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
PRS Account HepNet Study House, German Liverfoundation
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP