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Acute Hepatitis CPhase 2NCT02309918

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

A Phase 2 study testing LDV/SOF FDC in people with Acute Hepatitis C, run by HepNet Study House, German Liverfoundation at 20 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Hepatitis C
What is being tested?
LDV/SOF FDC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
20 sitesGermany
Study dates
Nov 2014to Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent
  • Male or female, age ≥ 18 years
  • HCV RNA ≥ 103 IU/mL at Screening
  • 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
  • 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
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  • Non-cirrhotic. Absence of cirrhosis will be determined based on clinical parameters or ultrasound
  • Body mass index (BMI) ≥ 18 kg/m2
  • Screening ECG without clinically significant abnormalities
  • Subjects must have the following laboratory parameters at screening:
  • Hemoglobin ≥ 10 g/dL
  • Platelets ≥ 90,000/µL
  • INR ≤1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
  • Albumin ≥ 3 g/dL
  • HbA1c ≤ 10%
  • Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft- Gault equation
  • Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
  • 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
  • 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.
  • Subject must be of generally good health as determined by the Investigator.
  • Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.

Who cannot join

  • 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.
  • Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
  • Clinical hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
  • Solid organ transplantation.
  • Significant pulmonary disease or significant cardiac disease.
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  • 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.
  • 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.
  • Significant drug allergy (such as anaphylaxis or hepatotoxicity).
  • Any prior treatment for HCV infection including prior exposure to any inhibitor of the NS5B and NS5A.
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • Infection with hepatitis B virus (HBV; defined as HBsAg-positive) or human immunodeficiency virus (HIV)
  • Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
  • 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.
  • Donation or loss of more than 400 ml blood within 2 months prior to Baseline/Day 1
  • 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.
  • Known hypersensitivity to LDV, SOF or formulation excipients

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Germany20 sites

  • • Charite, Universitätsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie

    Berlin, 13353

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53105

  • Medizinisches Versorgungszentrum

    Düsseldorf, 40237

  • • Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie

    Essen, 45122

  • Universitätsklinikum Frankfurt, Medizinische Klinik 1

    Frankfurt, 60590

  • Universitätsklinikum Freiburg, Klinik für Innere Medizin II, Gastroenterologie, Hepatologie, Endokrinologie und Infektiologie

    Freiburg im Breisgau, 79106

  • Ifi, Institut für Interdisziplinäre Medizin

    Hamburg, 20099

  • Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik und Poliklinik

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

    Hanover, 30625

  • Universitätsklinikum Heidelberg, Gastroenterologie, Infektionen, Vergiftungen

    Heidelberg, 69120

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne, 44623

  • Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Klinik für Innere Medizin II - Gastroenterologie und Endokrinologie

    Homburg, 66421

  • Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin 1, Gastroenterologie, Hepatologie, Ernährungs- und Altersmedizin

    Kiel, 24105

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie und Rheumatologie

    Leipzig, 4103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, I. Medizinische Klinik und Poliklinik

    Mainz, 55131

  • Oberberg City München

    München, 80331

  • Klinikum rechts der Isar der TU-München, II. Medizinische Klinik und Poliklinik (Gastroenterologie)

    München, 81675

  • Medizinisches Versorgungszentrum Offenburg GmbH, St. Josefklinik, Ambulante Gastroenterologie

    Offenburg, 77654

  • Universitätsklinikum Tübingen, Innere Medizin I, Hepatologie, Gastroenterologie, Infektiologie

    Tübingen, 72076

  • Universitätsklinikum Würzburg,Medizinische Klinik und Poliklinik II, Zentrum Innere Medizin

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Interferon-free Treatment of Acute Genotype 1 Hepatitis C Virus Infection With Ledipasvir/Sofosbuvir Fixed-Dose Combination - The HepNet Acute HCV IV Study

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.

Being tested
LDV/SOF FDC
Keywords
acute HCV Genotype 1 Infection, HCV RNA, LDV/SOF FDC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LDV/SOF FDCDrug

    Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily

Study groups in NCT02309918
Study groupRoleWhat they receive
LDV/SOF FDCOtherLedipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily
Receives: Drug: LDV/SOF FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: 12 weeks

  2. Safety and tolerability of LDV/SOF FDC-containing regimens (frequency of AEs and SAEs)

    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.

    Measured: 24 weeks after treatment

Secondary outcomes (3)

  1. Durability of response (proportion of subjects with sustained viral response (HCV RNA < LLOQ TND)

    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).

    Measured: 24 weeks after treatment

  2. Kinetics of circulating HCV RNA (mean viral load)

    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)

    Measured: 24 weeks after treatment

  3. Emergence of viral resistance to LDV/SOF FDC

    To evaluate the emergence of viral resistance to LDV/SOF FDC during treatment and after treatment discontinuation

    Measured: 24 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02309918
Sponsor's protocol ID
HepNet-aHCV-IV
Other IDs
2013-001081-42
Status last verified
Aug 2017
First submitted
4 Nov 2014
Last updated
28 Aug 2017
Results posted
No
Data monitoring committee
No

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, Zollner 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.

    PubMed 28029529

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF FDC in people with Acute Hepatitis C, run by HepNet Study House, German Liverfoundation at 20 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02309918, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.

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