Interferon-free Treatment of Acute Genotype 1 Hepatitis C Virus Infection with Ledipasvir/Sofosbuvir

Phase 1

Conditions: Adults with acute genotype 1 hepatitis C virus (HCV) infection
MedDRA version: 18.1Level: LLTClassification code 10072848Term: Hepatitis C virus genotype 1 positiveSystem Organ Class: 100000004848
MedDRA version: 18.1Level: PTClassification code 10065051Term: Acute hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 100000004848
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-001081-42-DE

Lead Sponsor: Hannover Medical School

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
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 parameter 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:
a) Hemoglobin = 10 g/dL
b) Platelets = 90,000/µL
c) INR =1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
d) Albumin =3 g/dL
e) HbA1c =10%
f) Creatinine clearance (CLcr) =60 mL/min, as calculated by the Cockcroft-Gault equation (Cockcroft and Gault 1976)
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, see Appendix 2 for definitions).
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 able to complete the study schedule of assessments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
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, a1 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 as described in Section 5.4 within 21 days of the Baseline/Day 1 visit. Use of Amiodaron as concomitant medication is prohibited as described in Section 5.4 within 60 days of Baseline/Day 1 visit.
18. Known hypersensitivity to LDV, SOF or formulation excipients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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