Hepatitis C, ChronicNCT01798576
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 1 site in Romania.
Trial summary
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. 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 alfa-2a and Ribavirin
- How many people
- 282 participants
- Where
- 1 siteRomania
- Study dates
- Nov 2012to Jun 2015
- 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: Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)
Who may be able to join
- Adult participants, >/= 18 years of age
- Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
- No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
- Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:
- Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)
- Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment
- No co-infection with hepatitis B or human immunodeficiency virus (HIV)
Who cannot join
- History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
- History of neurological disease
- History of severe psychiatric disease
- Decompensated diabetes
- History of immunologically mediated disease
- History of severe cardiac disease
Show all 10Show fewer
- History or evidence of severe chronic pulmonary disease
- Inadequate hematologic function
- Pregnant or breastfeeding women
- Male partners of pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Pegylated Interferon 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.
Pegylated Interferon alfa-2aDrug
Also called Peginterferon alfa 2A
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
RibavirinDrug
Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated interferon alfa-2a | Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs) Receives: Drug: Pegylated Interferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse)
Measured: approximately 3 years
Secondary outcomes (6)
Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse)
Measured: approximately 3 years
Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse)
Measured: approximately 3 years
Percentage of patients with non-response/relapse/virological breakthrough/virological rebound
Measured: approximately 3 years
Duration of treatment
Measured: approximately 3 years
Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds
Measured: approximately 3 years
Safety: Incidence of adverse events
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
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
- 282 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
- NCT01798576
- Sponsor's protocol ID
- ML28498
- Status last verified
- Sep 2016
- First submitted
- 22 Feb 2013
- Last updated
- 15 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Observational Study on Retreatment of Chronic Hepatitis C Patients Previous Treatment Failure, Using Peginterferon Alfa-2a and Ribavirin Based Regimens
- ClinicalTrials.gov ID
- NCT01798576
- Acronym / sponsor ID
- ML28498
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Feb 2013 (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 prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated interferon alfa-2a | – | Drug: Pegylated Interferon alfa-2a, Drug: RibavirinParticipants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment-experienced participants with chronic hepatitis C receiving re-treatment with Pegasys plus ribavirin or regimens containing direct-acting antivirals (DAAs)
Key inclusion criteria (7 listed)
- Adult participants, >/= 18 years of age
- Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin
- No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label
- Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:
Key exclusion criteria (10 listed)
- History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C
- History of neurological disease
- History of severe psychiatric disease
- Decompensated diabetes
- History of immunologically mediated disease
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 |
|---|---|---|
| Pegylated Interferon alfa-2aAlso: Peginterferon alfa 2ADosing was at the discretion of the investigator in accordance with local clinical practice and local labelling. | Drug | Pegylated interferon alfa-2a |
| RibavirinDosing was at the discretion of the investigator in accordance with local clinical practice and local labelling. | Drug | Pegylated interferon alfa-2a |
Primary outcome
Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse)
Time frame: approximately 3 years
6 secondary outcomes
Percentage of patients with rapid virological response (RVR), defined as HCV RNA <50 IU/mL at Week 4 (overall and stratified by prior treatment outcome: non-response and relapse)
Time frame: approximately 3 years
Percentage of patients with early virological response (EVR), defined as HCV RNA <50 IU/mL or an at least 2-log drop from baseline in HCV RNA at Week 12, but with no RVR (overall and stratified by prior treatment outcome: non-response and relapse)
Time frame: approximately 3 years
Percentage of patients with non-response/relapse/virological breakthrough/virological rebound
Time frame: approximately 3 years
Duration of treatment
Time frame: approximately 3 years
Time to safety-related dose reduction/treatment discontinuation of any of the treatment compounds
Time frame: approximately 3 years
Safety: Incidence of adverse events
Time frame: approximately 3 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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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
1 site 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 1 site in Romania.
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 10 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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 was stopped early. 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?
Sustained virological response (SVR) rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment (overall and stratified by prior treatment outcome: non-response and relapse) (time frame: approximately 3 years). 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 15 Sep 2016.