Hepatitis C, ChronicNCT02557646
An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 27 sites in Hungary.
Trial summary
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated… 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?
- Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 697 participants
- Where
- 27 sitesHungary
- Study dates
- May 2009to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
Who may be able to join
- Participants with serologically confirmed chronic hepatitis C
- Participants using and accepting a double method of contraception
Who cannot join
- Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
- Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
- Participants previously treated with pegylated interferon and/or ribavirin
- Hepatitis B and Human Immunodeficiency Virus co-infections
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Hungary27 sites
Study site
Ajka, H-8400
Study site
Balassagyarmat, 2660
Study site
Békéscsaba, 5600
Study site
Budapest, 1067
Study site
Budapest, 1083
Study site
Budapest, 1088
Study site
Budapest, 1097
Study site
Budapest, H-1125
Study site
Debrecen, 4032
Study site
Debrecen, H-4031
Study site
Győr, 9004
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Kecskemét, 6000
Study site
Miskolc, 3529
Study site
Miskolc, H-3501
Study site
Nyíregyháza, 4400
Study site
Pécs, 7623
Study site
Pécs, 7624
Study site
Sopron, 9400
Study site
Szeged, 6720
Study site
Székesfehérvár, 8000
Study site
Szekszárd, 7100
Study site
Szolnok, 5000
Study site
Szombathely, 9700
Study site
Tatabánya, 2800
Study site
Zalaegerszeg, 8900
About this study
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, 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.
Peginterferon alfa-2aBiological
Also called Pegasys
Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
RibavirinDrug
Also called Copegus
Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
| Study group | Role | What they receive |
|---|---|---|
| Pegasys + Copegus | Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee. Receives: Biological: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
Measured: 24 weeks after EOT (maximum up to 96 Weeks)
Secondary outcomes (14)
Percentage of Participants With Virologic Response
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.
Measured: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.
Measured: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.
Measured: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.
Measured: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.
Measured: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Measured: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Measured: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
Measured: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to IL-28B Polymorphism
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.
Measured: 24 weeks after EOT (maximum up to 96 Weeks)
Percentage of Participants With Viral Relapse or Breakthrough
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.
Measured: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.
Measured: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.
Measured: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.
Measured: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.
Measured: Up to 24 weeks after EOT (maximum up to 96 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557646
- Sponsor's protocol ID
- ML22453
- Status last verified
- Feb 2016
- First submitted
- 22 Sep 2015
- Last updated
- 28 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT02557646
- Acronym / sponsor ID
- ML22453
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 10 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegasys + Copegus | – | Biological: Peginterferon alfa-2a, Drug: RibavirinTreatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.
Key inclusion criteria (2 listed)
- Participants with serologically confirmed chronic hepatitis C
- Participants using and accepting a double method of contraception
Key exclusion criteria (4 listed)
- Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
- Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
- Participants previously treated with pegylated interferon and/or ribavirin
- Hepatitis B and Human Immunodeficiency Virus co-infections
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysParticipants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P | Biological | Pegasys + Copegus |
| RibavirinAlso: CopegusParticipants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs. | Drug | Pegasys + Copegus |
Primary outcome
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin
Time frame: 24 weeks after EOT (maximum up to 96 Weeks)
Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.
14 secondary outcomes
Percentage of Participants With Virologic Response
Time frame: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)
Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin
Time frame: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Starting Dose of Ribavirin
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin
Time frame: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin
Time frame: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to Dose Reduction of Ribavirin
Time frame: 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism
Time frame: Up to EOT (maximum up to 72 weeks)
Percentage of Participants With SVR According to IL-28B Polymorphism
Time frame: 24 weeks after EOT (maximum up to 96 Weeks)
Percentage of Participants With Viral Relapse or Breakthrough
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin
Time frame: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin
Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study director
Hoffmann-La Roche
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 27 sites in Hungary.
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 2 inclusion and 4 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Hungary. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Virological Response (SVR) According to Cumulative Dose of Ribavirin (time frame: 24 weeks after EOT (maximum up to 96 Weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2016.