Chronic Hepatitis CPhase 4CONTRANCT01684787
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
A Phase 4 study testing Peginterferon alfa-2a + ribavirin in normal ALT and Peginterferon alfa-2a + ribavirin in elevated ALT in people with Chronic Hepatitis C, run by Miguel Santin at 18 sites in Spain.
Trial summary
In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis. Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa-2a + ribavirin in normal ALT and Peginterferon alfa-2a + ribavirin in elevated ALT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 18 sitesSpain
- Study dates
- Sep 2006to Jun 2011
- 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 over 18 years old
- Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
- CD4 > 200 cel/mL
- Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
- Negative contraception test
- Informed consent signed
Who cannot join
- Pregnancy
- Any previous treatment for CHC
- Any experimental treatment in the 6 previous weeks to the inclusion
- Cirrhosis grade B or C (Child-Pugh)
- Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
- Hepatic cancer
Show all 10Show fewer
- Neutrophils < 1500 cel/mL, Platelets < 70000 cel/mL, Hemoglobin < 11 g/dL (men) or < 12 g/dL (women) previous to inclusion
- Severe psychiatric illness background
- Serum creatinin > 1,5 times the upper normal limit
- Background of Pulmonary or Cardiovascular disease
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Clinic
Barcelona, Barcelona, 08036
Consorci Sanitari Integral
Hospitalet, Barcelona, 08907
Hospital Universitari of Bellvitge
Hospitalet, Barcelona, 08907
Hospital San Jorge
Huesca, Huesca, 22004
Hospital de la Princesa
Madrid, Madrid, 28006
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital General de Mataró
Mataró, Barcelona, 08304
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014
Hospital Joan XXIII
Tarragona, Tarragona, 43007
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
Hospital Xeral-Cíes
Vigo, Pontevedra, 36204
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, 01009
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients
In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.
Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.
Read more
The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.
In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.
In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.
This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.
The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.
Read the detailed description
The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa-2a + ribavirin in normal ALT, Peginterferon alfa-2a + ribavirin in elevated ALT
- Keywords
- chronic hepatitis C, normal ALT, HIV/HCV patients
- 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-2a + ribavirin in normal ALTDrug
Also called Pegasys + ribavirin
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Peginterferon alfa-2a + ribavirin in elevated ALTDrug
Also called Pegasys + ribavirin
peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peginterferon alfa-2a + ribavirin in normal ALT Receives: Drug: Peginterferon alfa-2a + ribavirin in normal ALT |
| 2 | Active comparator | peginterferon alfa-2a + ribavirin in elevated ALT Receives: Drug: Peginterferon alfa-2a + ribavirin in elevated ALT |
What is being measured
The primary outcome is the main question the study is designed to answer.
% patients with RNA-HCV negative
Measured: 24 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2006
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Santin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miguel Santin, Hospital Universitari de Bellvitge
- Investigators
- Miguel Santin, Dr, Study chair, Hospital Universitari of Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684787
- Sponsor's protocol ID
- Miguel Santín
- Acronym
- CONTRA
- Status last verified
- Sep 2012
- First submitted
- 11 Jun 2010
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Multicentre, Phase IV Study to Evaluate Efficacy and Safety of Pegylated Interferon Alpha-2a (40 KD) Plus Ribavirin for Chronic Hepatitis C With Normal Transaminases in Human Immunodeficiency Virus-infected Patients
- ClinicalTrials.gov ID
- NCT01684787
- Acronym / sponsor ID
- CONTRA / Miguel Santín
- Conditions
- Chronic Hepatitis C
- Keywords
- chronic hepatitis C, normal ALT, HIV/HCV patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Miguel SantinUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 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.
In the current practice patients with normal levels of ALT were not treated. However, a percentage of patients will present an advanced grade of fibrosis and cirrhosis.
Another reason to treat is the similar response to the treatment than elevated ALT patients published recently in mono-infected patients.
The investigators have not data concerning the evolution and response to the treatment in co-infected patients with normal ALT.
In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it assumes a behavior similar between mono and co-infected patients and the results are different.
In the case of normal ALT the investigators do not know if the natural history in co-infected patients is similar than the mono-infected patients, and also the response of the treatment.
This study prospective and controls is the answer of this question. The main hypothesis is if the response of treatment in co-infected patients is not inferior than mono-infected patients.
The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning genotype, gender and hospital.
Detailed description
The treatment of co-infected patients with normal ALT would be very important because the evolution of cirrhosis in this patients is quicker and frequently than mono-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Peginterferon alfa-2a + ribavirin in normal ALTPeginterferon alfa-2a + ribavirin in normal ALT |
| 2 | Active comparator | Drug: Peginterferon alfa-2a + ribavirin in elevated ALTpeginterferon alfa-2a + ribavirin in elevated ALT |
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 over 18 years old
- Hepatitis C co infected with stable HIV-1 and normal ALT (CASE) or elevated levels of ALT (CONTROL)
- CD4 > 200 cel/mL
- Stable anti-retroviral treatment for HIV during at least, the 6 previous months to the inclusion
- Negative contraception test
Key exclusion criteria (10 listed)
- Pregnancy
- Any previous treatment for CHC
- Any experimental treatment in the 6 previous weeks to the inclusion
- Cirrhosis grade B or C (Child-Pugh)
- Treatment with colony-stimulating factors, didanosine or zidovudine, immunomodulator therapy, isoniazid, rifampicin, …
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-2a + ribavirin in normal ALTAlso: Pegasys + ribavirinpeginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily | Drug | 1 |
| Peginterferon alfa-2a + ribavirin in elevated ALTAlso: Pegasys + ribavirinpeginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily | Drug | 2 |
Primary outcome
% patients with RNA-HCV negative
Time frame: 24 weeks after 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 13 Sep 2012.
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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.
Miguel Santin, Dr study chair
Hospital Universitari of Bellvitge
18 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 Peginterferon alfa-2a + ribavirin in normal ALT and Peginterferon alfa-2a + ribavirin in elevated ALT in people with Chronic Hepatitis C, run by Miguel Santin at 18 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 6 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: finished, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
% patients with RNA-HCV negative (time frame: 24 weeks after 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 13 Sep 2012; AzTrials last refreshed its copy on 26 Oct 2026.