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Hepatitis C, ChronicPhase 4OPTEX2/3NCT00803309

Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

A Phase 4 study testing pegylated interferon alpha-2b and Ribavirin in people with Hepatitis C, Chronic, run by HepNet Study House, German Liverfoundation at 49 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
pegylated interferon alpha-2b and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
49 sitesGermany
Study dates
Nov 2008to Aug 2013
Phase
Phase 4
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

  • Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
  • Age ≥ 18 years
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
  • Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and > 10.6 mg/kg ribavirin (Rebetol®)
  • No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
  • Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

Who cannot join

  • Women with ongoing pregnancy or breast feeding
  • Male partners of women who are pregnant
  • Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
Show all 28Show fewer
  • Absolute neutrophil count (ANC) <750 cells/mm3 at screening
  • Platelet count <50,000 cells/mm3 at screening
  • Hb <10 g/dl at screening
  • Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
  • Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
  • Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
  • History or any other evidence of autoimmune diseases
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
  • Evidence of thyroid disease that is poorly controlled on prescribed medications
  • Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
  • History of major organ transplantation with an existing functional graft
  • History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Patients with evidence for tuberculosis
  • Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
  • Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
  • Limited contractual capability

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

Germany49 sites

  • Ärztehaus Leipziger Straße

    Berlin, 10117

  • Medizinisches Infektiologiezentrum

    Berlin, 10439

  • Praxis Dr. med. Naumann

    Berlin, 10627

  • Hepatologische Schwerpunktpraxis im bng

    Berlin, 10969

  • Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie

    Berlin, 13353

  • Praxis Dr. med. J. Gölz

    Berlin, 14057

  • Praxis Meyer

    Berlin, 14057

  • Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I

    Bonn, 53105

  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28205

  • Kreiskliniken Burghausen/Altötting, Med. Klinik II

    Burghausen/Altötting, 84489

  • Hepatologische Schwerpunktpraxis im bng

    Dortmund, 44263

  • Krankenhaus Dresden-Friedrichstadt

    Dresden, 01067

  • Fachärztliche Gemeinschaftspraxis

    Düsseldorf, 40223

  • Universitätsklinikum Essen

    Essen, 45122

  • Klinikum der J.W. Goethe-Universität

    Frankfurt, 60590

  • Vitanus GmbH

    Frankfurt, 60596

  • Praxis Zentrum Gastroenterologie und Endokrinologie

    Freiburg im Breisgau, 79098

  • Asklepios Klinik St. Georg, Institut für interdiziplinäre Infektiologie

    Hamburg, 20099

  • IPM-Studycenter GmbH & Co. KG

    Hamburg, 20099

  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin

    Hamburg, 20246

  • Universtätsklinikum Hamburg-Eppendorf;Innere Medizin

    Hamburg, 20246

  • Praxis Dr. med. S. Holm

    Hanover, 30159

  • Leberpraxis Hannover

    Hanover, 30161

  • Medizinische Hochschule Hannover, Zentrum Innere Medizin

    Hanover, 30625

  • Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV

    Heidelberg, 69120

  • Hepatologische Schwerpunktpraxis im bng

    Herne, 44623

  • Universitätskliniken des Saarlandes, Innere Medizin II, Gastroenterologie

    Homburg, 66424

  • Klinik für Innere Medizin der FSU

    Jena, 07747

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Allgemeine Innere Medizin

    Kiel, 24105

  • Gastroenterologische Gemeinschaftspraxis

    Kiel, 24146

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Gemeinschaftspraxis Dr.Simon

    Leverkusen, 51375

  • Universitätklinikum Schleswig-Holstein, Campus Lübeck, Med. Klinik I

    Lübeck, 23538

  • Otto-von-Guericke Universität Magdeburg

    Magdeburg, 39120

  • Klinikum der Johannes Gutenberg Universität Med. Klinik

    Mainz, 55131

  • Universitäts-Klinikum Mannheim, Med. Klinik II

    Mannheim, 68167

  • Hepatologische Schwerpunktpraxis im bng

    Minden, 32423

  • Klinikum Großhadern, Med. Klinik 2

    München, 81366

  • Universitätsklinikum Münster, Med. Klinik und Poliklinik B

    Münster, 48149

  • St.-Theresien-Krankenhaus

    Nuremberg, 90491

  • St. Josef Hospital

    Oberhausen, 46045

  • Hepatologische Schwerpunktpraxis im bng

    Offenbach, 63065

  • St.-Josefs-Klinik, Med. Klinik

    Offenburg, 77654

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin I

    Regensburg, 93053

  • Diakoniekrankenhaus, Med. Klinik II

    Rotenburg (Wümme), 27356

  • Praxis Dr. med. A. Trein

    Stuttgart, 70197

  • Universitätsklinikum Tübingen Medizinische Klinik I

    Tübingen, 70206

  • Universitätsklinikum Ulm, Abteilung für Innere Medizin I

    Ulm, 89081

  • Med. Poliklinik der Universität Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin.

The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.

Being tested
pegylated interferon alpha-2b, Ribavirin
Keywords
Chronic HCV-genotype 2/3, Efficacy of treatment extension, PegIntron, pegylated interferon alpha-2b, Rebetol, ribavirin
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • pegylated interferon alpha-2bDrug

    Also called PegIntron

    1.5 µg/kg once weekly, syringe, 24 weeks

  • RibavirinDrug

    Also called Rebetol

    800-1400 mg per os, daily, tablets, 24 weeks

  • pegylated Interferon alpha-2bDrug

    Also called PegIntron

    1.5 µg/kg once weekly, syringe, 12 weeks

  • RibavirinDrug

    Also called Rebetol

    800-1400 mg per os, daily, tablets, 12 weeks

Study groups in NCT00803309
Study groupRoleWhat they receive
AActive comparatorPegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up
Receives: Drug: pegylated interferon alpha-2b; Drug: Ribavirin
BActive comparatorPegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up
Receives: Drug: pegylated Interferon alpha-2b; Drug: Ribavirin

What is being measured

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

  1. Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR)

    Measured: 48 weeks (arm A) or 36 weeks (arm B)

Secondary outcomes (4)

  1. Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) at the end of therapy

    Measured: 24 weeks (arm A) or 12 weeks (arm B)

  2. Biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up.

    Measured: Arm A: 24 and 24 weeks, arm B: 12 and 24 weeks

  3. Severity and frequency of adverse event

    Measured: 48 weeks (arm A) or 36 weeks (arm B)

  4. Analysis of quality of life

    Measured: 48 weeks (arm A) or 36 weeks (arm B)

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 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2013
  4. Study completionAug 2013

Why it stopped: At the end of the planned recruitment period the expected number of subjects could not be included in the trial.

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00803309
Sponsor's protocol ID
P05498
Acronym
OPTEX2/3
Status last verified
Aug 2017
First submitted
4 Dec 2008
Last updated
28 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Heidrich B, Cordes HJ, Klinker H, Moller B, Naumann U, Rossle M, Kraus MR, Boker KH, Roggel C, Schuchmann M, Stoehr A, Trein A, Hardtke S, Gonnermann A, Koch A, Wedemeyer H, Manns MP, Cornberg M. Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial): A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial. PLoS One. 2015 Jun 9;10(6):e0128069. doi: 10.1371/journal.pone.0128069. eCollection 2015.

    PubMed 26057627

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing pegylated interferon alpha-2b and Ribavirin in people with Hepatitis C, Chronic, run by HepNet Study House, German Liverfoundation at 49 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 7 inclusion and 28 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: stopped early, 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 49 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: At the end of the planned recruitment period the expected number of subjects could not be included in the trial.). Results are not available in the source record.

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?

Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR) (time frame: 48 weeks (arm A) or 36 weeks (arm B)). 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 NCT00803309, 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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