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Chronic Hepatitis CNCT00854802

A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

A study testing Debio 025, Peg-IFNα2a and Ribavirin in people with Chronic Hepatitis C, run by Debiopharm International SA at 40 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C
What is being tested?
Debio 025, Peg-IFNα2a and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
40 sitesin 7 countries
Study dates
Jan 2009to Sep 2010
Phase
Interventional
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females aged ≥ 18 and ≤ 65 years.
  • Body mass index (BMI) ≥ 18 and ≤ 32 kg/m^2.
  • Hepatitis B surface antigen (HbsAg) negative and HIV-1 negative.
  • Serological diagnosis of chronic hepatitis C viral infection genotype 1 for > 6 months.
  • Chronic liver disease consistent with chronic hepatitis C infection on a biopsy or FibroScan® obtained within the past 24 months (36 months for patients with incomplete/transition to cirrhosis).
  • Previously untreated for hepatitis C virus (HCV) infection (approved or investigational drug).
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  • Plasma HCV RNA level lower limit ≥ 100 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent; no upper limit.
  • Neutrophil count ≥ 1500/µL; hemoglobin (Hb) ≥ 12g/dL for females and ≥ 13g/dL for males; platelets ≥ 90,000/µL.
  • Patients with incomplete/transition to cirrhosis on biopsy or an elasticity score between 9.5 and 14 kPa on FibroScan must have an abdominal ultrasound (US), computed tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomisation) and a serum alpha-foetoprotein (AFP) < 100 ng/mL.
  • Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) < 5 times the upper limit of normal.
  • Normal or compensated liver function and absence of complicated portal hypertension as documented by the following:
  • No history of bleeding oesophageal varices;
  • Absence of ascites;
  • Absence of encephalopathy;
  • Albumin ≥ 35 g/L;
  • Total bilirubin ≤ 1.8 mg/dL (≤ 30 µmol/L);
  • Prothrombin (INR ≤ 1.5).
  • Creatinine clearance > 50 mL/min.
  • Thyroid stimulating hormone (TSH) within normal range;
  • All patients should be informed about Debio 025 and ribavirin foetotoxicity:
  • Females may participate if they are surgically sterile or post-menopausal. Pre-menopausal females may participate if they use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 4 months after the last Debio 025 or ribavirin dose.
  • Male patients must be surgically sterile or use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 7 months after the last Debio 025 or ribavirin dose.
  • Signed informed consent before any study procedures.
  • Negative pregnancy test within one week of first investigational product administration for female patients of child bearing potential.

Who cannot join

  • Treatment with any investigational drug within 6 months prior to the first dose of investigational product.
  • HCV genotype different from genotype 1.
  • Any previous HCV treatment (approved or investigational).
  • Histologic evidence of complete hepatic cirrhosis (including compensated cirrhosis) based on a previous liver biopsy (if available).
  • Ongoing or recent use of any other medication (including over the counter medication and herbal products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome P450 (CYP450) 3A, substrates of P-glycoprotein 1 (P-gP), or substrates/inhibitors of organic anion-transporting polypeptides (OATP), multidrug resistance-associated protein 2 (MRP2), or bile salt export pump (BSEP) and are mentioned in the list of unauthorised medications;
  • Any medical contraindications to peg-IFNα2a and/or ribavirin treatment;
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  • Any other cause of relevant liver disease other than HCV including but not limited to hepatitis B virus (HBV), drug- or alcohol-related cirrhosis, autoimmune hepatitis, haemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), or primary biliary cirrhosis (PBC).
  • Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study. Patients with risk factors (hypertension or diabetes) need to have an ophthalmologic investigation (including fundoscopy).
  • History of moderate, severe, or uncontrolled psychiatric disease, especially depression, including a history of hospitalisation or prior suicidal attempt.
  • Uncontrolled arterial hypertension, ie, patients with systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg.
  • History of pancreatitis, uncontrolled diabetes mellitus, or retinopathy.
  • Anti-nuclear antibody (ANA) titre > 1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
  • Alcohol consumption > 20 g/day for females and > 30 g/day for males.
  • History of major organ transplantation with an existing functional graft.
  • Pregnancy or lactation.
  • Haemoglobinopathies (thalassaemia major, sickle cell anaemia or drepanocytosis).
  • Familial history of severe neonatal cholestasis or pregnancy cholestasis.
  • Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is ≥ 20% within 2 years.

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

Germany9 sites

  • Charité - Universitatsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Center for HIV and Hepatogastroenterology

    Düsseldorf, 40237

  • Universitätsklinikum Essen

    Essen, 45122

  • J.W. Goethe University Hospital

    Frankfurt am Main, 60590

  • Albert-Ludwigs-Universität Freiburg, Universitätsk

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 30623

  • Medizinische Universitätsklinik

    Heidelberg, 69120

  • Johannes Gutenberg-Universitaet Mainz

    Mainz, 55101

Other trials in Germany

France7 sites

  • C.H.U - Hôpital Henri-Mondor

    Créteil, 94010

  • C.H.U de Lyon Hôpital de l'Hôtel Dieu

    Lyon, 69288

  • Hôpital de l'Archet 2

    Nice, 06202

  • C.H.U Hôpital Cochin

    Paris, 75679

  • C.H.U - Hôpital Saint Antoine

    Paris - Saint Antoine, 75571

  • Hôpital du Haut-Levêque - C.H.U de Bordeaux

    Pessac, 33604

  • C.H.U de Nancy-Hôpital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Poland7 sites

  • Wojewódzki Szpital Specjalistyczny im. K. Dluskieg

    Bialystok, 15-540

  • Wojewódzki Szpital Obserwacyjno-Zakazny im. Tadeus

    Bydgoszcz, 85-030

  • Szpital Specjalistyczny w Chorzowie

    Chorzów, 41-500

  • Wojewódzki Szpital Zespolony w Kielcach

    Kielce, 25-736

  • Krakowski Szpital Specjalistyczny im. Jana Pawla I

    Krakow, 31-202

  • Wojewódzki Szpital Specjalstyczny im. Wl. Biegansk

    Lódz, 91-347

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Woj

    Warsaw, 01-201

Other trials in Poland

Italy5 sites

  • Policlinico S.Orsola Malpighi

    Bologna, 40138

  • Mangiagalli e Regina Elena di Milano

    Milan, 20122

  • Seconda Università di Napoli- Secondo Policlinico

    Naples, 80131

  • "Policlinico ""Paolo Giaccone"" dell'Università di

    Palermo, 90127

  • Az. Osp. Universitaria S. Giovanni Battista

    Torino, 10126

Other trials in Italy

Romania5 sites

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • Centrul de Diagnostic si Tratament Dr. Victor Babe

    Bucharest, 30303

  • "Spitalul Clinic de Urgenta ""Prof. dr. Octavian F

    Cluj-Napoca, 400162

  • Institutul de Gastroenterologie si Hepatologie

    Iași, 700111

Other trials in Romania

Spain5 sites

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 8035

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 8916

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario Puerta de Hierro

    Madrid, 28035

  • Hospital Universitario Nuestra Señora de Valme

    Seville, 41014

Other trials in Spain

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.

Read the detailed description

This is an international, multicentre, randomised, double-blind, placebo-controlled, 4-arm, parallel-group, multiple dose phase II study comparing 3 Debio 025 (alisporivir)/peg-IFNα2a/ribavirin regimens to SOC treatment in treatment naïve chronic HCV genotype 1 patients.

Patients are randomised into 1 of 4 arms receiving either Debio 025/peg-IFNα2a/ribavirin triple therapy for a fixed treatment duration of 48 weeks (Treatment A) or 24 weeks (Treatment B), Debio 025/peg-IFNα2a/ribavirin triple therapy for a response-based treatment duration of 24 or 48 weeks (Treatment C), or blinded SOC treatment for 48 weeks (Treatment D). Follow-up is 24 weeks in all treatment arms.

Being tested
Debio 025, Peg-IFNα2a, Ribavirin, Debio 025 placebo
Keywords
Hepatitis, Hepatitis C
Medical subject headings
Hepatitis C, Chronic, Hepatitis, Hepatitis C

What participants receive

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

  • Debio 025Drug

    Also called Alisporivir

    Debio 025 supplied in soft gel capsules

  • Peg-IFNα2aDrug

    Also called Pegasys

    Peg-IFNα2a supplied in pre-filled syringes

  • RibavirinDrug

    Also called Copegus, Rebetol, Ribasphere, Vilona

    Ribavirin supplied in tablets

  • Debio 025 placeboDrug

    Debio 025 placebo supplied in soft gel capsules

Study groups in NCT00854802
Study groupRoleWhat they receive
Debio 025 600 mg + peg-IFNα2a + ribavirin - 48 weeksExperimentalParticipants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 47 weeks + peg-IFNα2a 180 µg subcutaneously (sc) once weekly for 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 48 weeks.
Receives: Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin
Debio 025 600 mg + peg-IFNα2a + ribavirin - 24 weeksExperimentalParticipants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 23 weeks + peg-IFNα2a 180 µg sc once weekly for 24 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 24 weeks.
Receives: Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin
Debio 025 600 mg + peg-IFNα2a + ribavirin - 24 or 48 weeksExperimentalParticipants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 23 or 47 weeks + peg-IFNα2a 180 µg sc once weekly for 24 or 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 24 or 48 weeks. Participants who achieve a rapid viral response, defined as having undetectable hepatitis C virus RNA at week 4, are treated for 24 weeks; other patients are treated for 48 weeks.
Receives: Drug: Debio 025; Drug: Peg-IFNα2a; Drug: Ribavirin
Debio 025 placebo + peg-IFNα2a + ribavirin - 48 weeksPlacebo comparatorParticipants receive Debio 025 placebo orally twice daily for 7 days followed by Debio 025 placebo orally once daily for 47 weeks + peg-IFNα2a 180 µg subcutaneously (sc) once weekly for 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 48 weeks.
Receives: Drug: Peg-IFNα2a; Drug: Ribavirin; Drug: Debio 025 placebo

What is being measured

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

  1. Percentage of participants achieving sustained viral response (SVR) 72 weeks after treatment start

    SVR is defined as hepatitis C virus (HCV) RNA < 10 IU/mL (undetectable).

    Measured: 72 weeks after treatment start

Secondary outcomes (6)

  1. Percentage of participants achieving a rapid viral response (RVR) after 4 weeks of treatment

    RVR is defined as HCV RNA level < 10 IU/mL after 4 weeks of treatment.

    Measured: 4 weeks after treatment start

  2. Percentage of participants achieving a complete early viral response (cEVR) after 12 weeks of treatment

    cEVR is defined as HCV RNA level < 10 IU/mL after 12 weeks of treatment.

    Measured: 12 weeks after treatment start

  3. Percentage of participants achieving an early viral response (EVR) after 12 weeks of treatment

    EVR is defined as a decrease from baseline of the HCV RNA level by > 2 log10 or undetectable (< 10 UI/mL) after 12 weeks of treatment.

    Measured: 12 weeks after treatment start

  4. Percentage of participants achieving an end-of-treatment response (ETR) at treatment end

    ETR is defined as HCV RNA level < 10 IU/mL at the end of treatment (Week 24 or Week 48).

    Measured: at end of treatment (Week 28 or Week 52)

  5. Percentage of participants achieving a sustained viral response 12 weeks after the end of treatment (SVR 12)

    SVR 12 is defined as HCV RNA level < 10 IU/mL 12 weeks after the end of treatment (Week 40 or Week 64).

    Measured: 12 weeks after end of treatment (Week 40 or Week 64)

  6. Percentage of participants with sustained viral response 24 weeks after the end of treatment (SVR 24)

    SVR 24 is defined as HCV RNA level < 10 IU/mL 24 weeks after the end of treatment (Week 52 or Week 76).

    Measured: 24 weeks after end of treatment (Week 52 or Week 76

Timeline

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

  1. First posted3 Mar 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00854802
Sponsor's protocol ID
Debio 025-HCV-205
Other IDs
2008-004605-34, CDEB025A2205, 2008
Status last verified
Feb 2016
First submitted
2 Mar 2009
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Paeshuyse J, Kaul A, De Clercq E, Rosenwirth B, Dumont JM, Scalfaro P, Bartenschlager R, Neyts J. The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology. 2006 Apr;43(4):761-70. doi: 10.1002/hep.21102.

    PubMed 16557546

  • Inoue K, Umehara T, Ruegg UT, Yasui F, Watanabe T, Yasuda H, Dumont JM, Scalfaro P, Yoshiba M, Kohara M. Evaluation of a cyclophilin inhibitor in hepatitis C virus-infected chimeric mice in vivo. Hepatology. 2007 Apr;45(4):921-8. doi: 10.1002/hep.21587.

    PubMed 17393519

  • Flisiak R, Horban A, Gallay P, Bobardt M, Selvarajah S, Wiercinska-Drapalo A, Siwak E, Cielniak I, Higersberger J, Kierkus J, Aeschlimann C, Grosgurin P, Nicolas-Metral V, Dumont JM, Porchet H, Crabbe R, Scalfaro P. The cyclophilin inhibitor Debio-025 shows potent anti-hepatitis C effect in patients coinfected with hepatitis C and human immunodeficiency virus. Hepatology. 2008 Mar;47(3):817-26. doi: 10.1002/hep.22131.

    PubMed 18302285

  • Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van Vliet A, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology. 2006 Oct;131(4):997-1002. doi: 10.1053/j.gastro.2006.07.013.

    PubMed 17030169

  • Pawlotsky JM. Treatment of hepatitis C: don't put all your eggs in one basket! Gastroenterology. 2007 Apr;132(4):1611-5. doi: 10.1053/j.gastro.2007.03.014. No abstract available.

    PubMed 17418174

  • Dienstag JL, McHutchison JG. American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):231-64; quiz 214-7. doi: 10.1053/j.gastro.2005.11.010. No abstract available.

    PubMed 16401486

  • Zeuzem S, Buti M, Ferenci P, Sperl J, Horsmans Y, Cianciara J, Ibranyi E, Weiland O, Noviello S, Brass C, Albrecht J. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol. 2006 Jan;44(1):97-103. doi: 10.1016/j.jhep.2005.10.003. Epub 2005 Nov 7.

    PubMed 16290907

  • Watashi K, Hijikata M, Hosaka M, Yamaji M, Shimotohno K. Cyclosporin A suppresses replication of hepatitis C virus genome in cultured hepatocytes. Hepatology. 2003 Nov;38(5):1282-8. doi: 10.1053/jhep.2003.50449.

    PubMed 14578868

  • Watashi K, Ishii N, Hijikata M, Inoue D, Murata T, Miyanari Y, Shimotohno K. Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell. 2005 Jul 1;19(1):111-22. doi: 10.1016/j.molcel.2005.05.014.

    PubMed 15989969

  • Rice CM, You S. Treating hepatitis C: can you teach old dogs new tricks? Hepatology. 2005 Dec;42(6):1455-8. doi: 10.1002/hep.20975.

    PubMed 16317665

  • Ishii N, Watashi K, Hishiki T, Goto K, Inoue D, Hijikata M, Wakita T, Kato N, Shimotohno K. Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol. 2006 May;80(9):4510-20. doi: 10.1128/JVI.80.9.4510-4520.2006.

    PubMed 16611911

  • Yang F, Robotham JM, Nelson HB, Irsigler A, Kenworthy R, Tang H. Cyclophilin A is an essential cofactor for hepatitis C virus infection and the principal mediator of cyclosporine resistance in vitro. J Virol. 2008 Jun;82(11):5269-78. doi: 10.1128/JVI.02614-07. Epub 2008 Apr 2.

    PubMed 18385230

Questions about this trial

What is this clinical trial studying?

A study testing Debio 025, Peg-IFNα2a and Ribavirin in people with Chronic Hepatitis C, run by Debiopharm International SA at 40 sites in 7 countries.

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 24 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Germany, France, Poland, Italy, Romania and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Percentage of participants achieving sustained viral response (SVR) 72 weeks after treatment start (time frame: 72 weeks after treatment start). 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 NCT00854802, which also lists 12 linked publications.

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 17 Feb 2016.

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