Hepatitis CPhase 4NCT00470210
Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
A Phase 4 study testing Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week, Ribavirin (Copegus®) 1600 mg/day and Epoetin β (450 UI/kg/week) in people with Hepatitis C and HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial summary
This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatitis C, HIV Infections
- What is being tested?
- Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week, Ribavirin (Copegus®) 1600 mg/day and Epoetin β (450 UI/kg/week)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- May 2007to Jun 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected patients coinfected with HCV genotypes 1 or 4
- Persistent transaminase elevation
- Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.
Who cannot join
- Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
- Patients with Child-Pugh B or C cirrhosis
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
About this study
Official title: Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens
This trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.
Read the detailed description
The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.
The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.
The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.
- Conditions
- Hepatitis C, HIV Infections
- Being tested
- Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week, Ribavirin (Copegus®) 1600 mg/day, Epoetin β (450 UI/kg/week)
- Keywords
- Ribavirin, non-responders, HCV co-infected patients, sustained virological response, Treatment Experienced
- Medical subject headings
- Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/weekDrug
Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week
Ribavirin (Copegus®) 1600 mg/dayDrug
Ribavirin (Copegus®) 1600 mg/day
Epoetin β (450 UI/kg/week)Drug
Epoetin β (450 UI/kg/week)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week) Receives: Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week; Drug: Ribavirin (Copegus®) 1600 mg/day; Drug: Epoetin β (450 UI/kg/week) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
Measured: 24 weeks after finishing treatment
Secondary outcomes (2)
Changes in serum HCV-RNA titers
Measured: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
Percentage of patients with serum HCV-RNA loads of < 50 IU/mL
Measured: at weeks 4, 8, 12, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Bonaventura Clotet, MD, PhD, Principal investigator, Germans Trias i Pujol HospitalCristina Tural, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470210
- Sponsor's protocol ID
- MORE
- Other IDs
- 2006-005554-74
- Status last verified
- Dec 2019
- First submitted
- 4 May 2007
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High-dose Ribavirin (1600 mg/d) Boosted With Epoetin β (450 IU/kg/wk) in HIV/HCV Coinfected Patients Not Responding to Previous Treatment Regimens
- ClinicalTrials.gov ID
- NCT00470210
- Acronym / sponsor ID
- MORE
- Conditions
- Hepatitis C, HIV Infections
- Keywords
- Ribavirin, non-responders, HCV co-infected patients, sustained virological response, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 May 2007 (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 trial will assess the sustained virologic response to treatment with peginterferon alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase elevations. These patients will have been nonresponders to previous regimens with peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.
Detailed description
The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin are associated with higher response rates than those achieved with ribavirin at dosages of 800-1200 mg/d.
The main aim of this trial is to assess the sustained virologic response to treatment with peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.
The second aim will be to measure changes in serum HCV-RNA titers and the percentage of patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend to evaluate the safety of this treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week, Drug: Ribavirin (Copegus®) 1600 mg/day, Drug: Epoetin β (450 UI/kg/week)Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week Ribavirin (Copegus®) 1600 mg/day Epoetin β (450 UI/kg/week) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected patients coinfected with HCV genotypes 1 or 4
- Persistent transaminase elevation
- Nonresponders to previous treatment with peginterferon alfa plus ribavirin at a dosage of 800-1200 mg/d.
Key exclusion criteria (2 listed)
- Patients who abandoned treatment with peginterferon plus ribavirin before 12 weeks
- Patients with Child-Pugh B or C cirrhosis
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 |
|---|---|---|
| Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/weekPeginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week | Drug | 1 |
| Ribavirin (Copegus®) 1600 mg/dayRibavirin (Copegus®) 1600 mg/day | Drug | 1 |
| Epoetin β (450 UI/kg/week)Epoetin β (450 UI/kg/week) | Drug | 1 |
Primary outcome
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL
Time frame: 24 weeks after finishing treatment
2 secondary outcomes
Changes in serum HCV-RNA titers
Time frame: between baseline and 4, 8, 12, 24, and 48 weeks after start of treatment
Percentage of patients with serum HCV-RNA loads of < 50 IU/mL
Time frame: at weeks 4, 8, 12, 24, and 48
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 5 Dec 2019.
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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.
Bonaventura Clotet, MD, PhD principal investigator
Germans Trias i Pujol Hospital
Cristina Tural, MD, PhD principal investigator
Germans Trias i Pujol Hospital
2 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 Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week, Ribavirin (Copegus®) 1600 mg/day and Epoetin β (450 UI/kg/week) in people with Hepatitis C and HIV Infections, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
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 5 Dec 2019. 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 Spain. 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?
Rate of sustained virologic response measured as serum HCV-RNA loads of < 50 IU/mL (time frame: 24 weeks after finishing 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 5 Dec 2019.