Hepatitis C, ChronicPhase 4NCT00351403
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
A Phase 4 study testing Ribavirin and Peginterferon alfa 2b in people with Hepatitis C, Chronic, run by FGK Clinical Research GmbH at 22 sites in Germany.
Trial summary
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Ribavirin and Peginterferon alfa 2b
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 22 sitesGermany
- Study dates
- Jul 2006to Jan 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
- Presence of a HCV genotype 1 infection
- Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value >= 13 g/dl in men, >= 12 g/dl in women - Leukocytes >= 3.000/mm3 or neutrophile granulocytes > 1.500/mm3 - Thrombocytes > 80.000/mm3
- Total bilirubin in the normal range
- Albumin in the normal range
- Serum creatinine in the normal range THS in the normal range
Who cannot join
- Alpha-Fetoprotein in the normal range
- Negative HIV test
- Negativity of Hepatitis B surface antigens (Hbs-Ag)
- Normal or elevated ALT/GTP values at screening
- At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
- Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
Show all 26Show fewer
- A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and 6 (women) to 7 (men) months after the therapy
- Age < 18 years, > 70 years
- Previous treatment of hepatitis c with (Peg)Interferon alfa or (Peg)Interferon alfa/Ribavirin
- Patients with organ transplantations other than cornea or hair
- Infection with HCV genotype 2,3,4,5 or 6
- Pregnant or nursing women
- Any other reason for the liver disease than chronic hepatitis C
- Suspected hypersensitivity to Interferon, Peginterferon or Ribavirin
- Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study
- Patients with any kind of hemoglobinopathy
- Documented liver disease in advanced state Liver cirrhosis Child B and C
- Each known and existing clinical conditions that might challenge the participation or completion of this clinical trial as depressions, psychosis, severe psychiatric diseases, suicide ideations CNS traumata or cramps which need medicamentous treatment
- Relevant cardiovascular dysfunctions in the last 6 months or patients with clinically relevant changes in the ECG
- Insufficiently adjusted diabetes mellitus
- Severe chronic lung diseases (as e.g. COPD)
- Immunologic diseases or autoimmune-diseases or any other disease which demand a longtime treatment with corticosteroids during this clinical trial
- Clinically relevant gout
- Abuse of drugs, alcohol or pharmaceuticals
- Patient with clinically relevant changes of the retina
- Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Germany22 sites
Universitätsklinikum Aachen
Aachen, Nordrhein.Westfalen, 52074
Hepatologische Schwerpunktpraxis
Berlin, State of Berlin, 10969
Charité, Campus Virchow-Klinikum
Berlin, State of Berlin, 13353
St. Josef-Hospital
Bochum, North Rhine-Westphalia, 44791
Universität zu Köln
Cologne, North Rhine-Westphalia, 50924
Gemeinschaftspraxis
Düsseldorf, North Rhine-Westphalia, 40237
Uniklinikum Erlangen
Erlangen, Bavaria, 91056
Medizinische Universitäts-Klinik Essen
Essen, North Rhine-Westphalia, 45122
Klinikum der J.W.-Goethe-Universität
Frankfurt am Main, Hesse, 60590
Praxis für Innere Medizin
Frankfurt am Main, Hesse, 60596
Medizinische Universitätsklinik Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinik Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitätsklinikum des Saarlandes
Homburg / Saar, Saarland, 66421
Christian-Albrechts-Universität zu Kiel
Kiel, Schleswig-Holstein, 24105
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Universitätsklinikum der J. Gutenberg Universität
Mainz, Rhineland-Palatinate, 55131
Klinikum Großhadern
München, Bavaria, 81377
Technische Universität München
München, Bavaria, 81675
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Klinikum der Universität Würzburg
Würzburg, Bavaria, 97080
About this study
Official title: Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity.
The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.
Read the detailed description
Further objectives of this trial are:
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.
To evaluate the biochemical response to the treatment (ALT values during and after the therapy) in comparison to the virological response to the treatment.
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.
To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Ribavirin, Peginterferon alfa 2b
- Keywords
- Chronic HCV infection, Genotype 1, Individually adapted therapy, Peginterferon alfa-2b, Ribavirin, Sustained viral response (SVR)
- 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.
RibavirinDrug
Rebetol 200 mg: applied as hard capsule
Peginterferon alfa 2bDrug
PegIntron (50/80/100/120/150 microgram): applied by injection
| Study group | Role | What they receive |
|---|---|---|
| Individualized therapy | Experimental | Lengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay. Receives: Drug: Ribavirin; Drug: Peginterferon alfa 2b |
| Historical control | Other | 48 week standard therapy Receives: Drug: Ribavirin; Drug: Peginterferon alfa 2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FGK Clinical Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Saarland
- Investigators
- Christoph Sarrazin, MD, PhD, Study chair, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351403
- Sponsor's protocol ID
- INDIV-2
- Other IDs
- 2006-000358-38
- Status last verified
- Feb 2010
- First submitted
- 11 Jul 2006
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Sarrazin C, Schwendy S, Moller B, Dikopoulos N, Buggisch P, Encke J, Teuber G, Goeser T, Thimme R, Klinker H, Boecher WO, Schulte-Frohlinde E, Prinzing R, Herrmann E, Zeuzem S, Berg T. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22.
PubMed 21784046
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Adapted Therapy Duration From 24 to 72 Weeks for the Treatment of a Chronic Hepatitis C Genotype 1 Infection With Peginterferon Alfa-2b Plus Ribavirin in Dependence of the Initial Concentration and the Decline of the HCV RNA
- ClinicalTrials.gov ID
- NCT00351403
- Acronym / sponsor ID
- INDIV-2
- Conditions
- Hepatitis C, Chronic
- Keywords
- Chronic HCV infection, Genotype 1, Individually adapted therapy, Peginterferon alfa-2b, Ribavirin, Sustained viral response (SVR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- FGK Clinical Research GmbHIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Saarland
- Study start
- Jul 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity.
The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.
Detailed description
Further objectives of this trial are:
To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72 weeks inclusive the adverse reactions and the withdrawal rates.
To evaluate the biochemical response to the treatment (ALT values during and after the therapy) in comparison to the virological response to the treatment.
To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a detection limit of 50 IU/ml.
To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic during the therapy on the response to the treatment in the different groups.
To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological therapy response, as well as the dependence of the serum concentration of Ribavirin on the creatinine clearance in comparison to the body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized therapy | Experimental | Drug: Ribavirin, Drug: Peginterferon alfa 2bLengh of therapy depends on time point when no HCV RNA is detectable in blood with Versant HCV Qualitative assay. |
| Historical control | Other | Drug: Ribavirin, Drug: Peginterferon alfa 2b48 week standard therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
- Presence of a HCV genotype 1 infection
- Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value >= 13 g/dl in men, >= 12 g/dl in women - Leukocytes >= 3.000/mm3 or neutrophile granulocytes > 1.500/mm3 - Thrombocytes > 80.000/mm3
- Total bilirubin in the normal range
- Albumin in the normal range
Key exclusion criteria (26 listed)
- Alpha-Fetoprotein in the normal range
- Negative HIV test
- Negativity of Hepatitis B surface antigens (Hbs-Ag)
- Normal or elevated ALT/GTP values at screening
- At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinRebetol 200 mg: applied as hard capsule | Drug | Historical control, Individualized therapy |
| Peginterferon alfa 2bPegIntron (50/80/100/120/150 microgram): applied by injection | Drug | Historical control, Individualized therapy |
Primary outcome
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
- Derived from this study: PubMed 21784046Sarrazin C, Schwendy S, Moller B, Dikopoulos N, Buggisch P, Encke J, Teuber G, Goeser T, Thimme R, Klinker H, Boecher WO, Schulte-Frohlinde E, Prinzing R, Herrmann E, Zeuzem S, Berg T. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Sarrazin, MD, PhD study chair
University Hospital, Saarland
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribavirin and Peginterferon alfa 2b in people with Hepatitis C, Chronic, run by FGK Clinical Research GmbH at 22 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 6 inclusion and 26 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 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?
Sustained viral response (HCV RNA negativity 24 weeks after end of treatment). 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 NCT00351403, 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 8 Feb 2010.