Hepatitis C, ChronicNCT01679834
An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 2 sites in Germany.
Trial summary
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 7,500 participants
- Where
- 2 sitesGermany
- Study dates
- 24 Nov 2014to 14 Jul 2017
- Phase
- Observational
- 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
Study population: Patients with chronic hepatitis C infection
Who may be able to join
- Adult patients, >/= 18 years of age
- Diagnosis of chronic hepatitis C
- Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label
Who cannot join
- Contraindications against Pegasys or Copegus
- Not willing or unable to sign written informed consent form
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.
- Conditions
- Hepatitis C, Chronic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Measured: 24 weeks after end of treatment
Secondary outcomes (3)
Rapid virological response
Measured: 4 weeks after start of treatment
Early Virological Response
Measured: 12 weeks after start of treatment
Safety: incidence of adverse events
Measured: up to 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 posted6 Sep 2012 (estimated)
- Study start24 Nov 2014
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 7,500 participants (estimated)
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
- NCT01679834
- Sponsor's protocol ID
- ML25724
- Status last verified
- Feb 2018
- First submitted
- 3 Sep 2012
- Last updated
- 1 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers
- ClinicalTrials.gov ID
- NCT01679834
- Acronym / sponsor ID
- ML25724
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 6 Sep 2012 (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.
This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C infection
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Diagnosis of chronic hepatitis C
- Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label
Key exclusion criteria (2 listed)
- Contraindications against Pegasys or Copegus
- Not willing or unable to sign written informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained virological response
Time frame: 24 weeks after end of treatment
3 secondary outcomes
Rapid virological response
Time frame: 4 weeks after start of treatment
Early Virological Response
Time frame: 12 weeks after start of treatment
Safety: incidence of adverse events
Time frame: up to 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 1 Mar 2018.
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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
2 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 2 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 3 inclusion and 2 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 virological response (time frame: 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?
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 1 Mar 2018.