Hepatitis CPhase 2TRITALNCT00856804
Thalidomide Plus Peginterferon and Ribavirin in Patients With Interferon Resistance
A Phase 2 study testing thalidomide in people with Hepatitis C, run by Valme University Hospital at 1 site in Spain.
Trial summary
INDICATION: Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for hepatitis C. OBJECTIVES: 1. ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with peginterferon + ribavirin resistance. 2. To know the response rate in 12 weeks 3. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 2
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women in non fertile age.
- HCV RNA detectable in serum.
- Chronic hepatitis C virus with non-cirrhotic compensated liver disease (clinical classification according to Child-Pugh Grade A) (Appendix 1).
- Genotype 1.
- Not responding to treatment with peginterferon alfa-2a in combination with Ribavirin.
- Effective contraceptive measures during treatment and for 6 months after treatment.
Who cannot join
- Patients with any of the following will not be selected for treatment:
- Patients with liver biopsy compatible with cirrhosis F4 Metav classification.
- Patients diagnosed with diabetes or basal glycemia higher than 126 mg / dl
- Women and men of childbearing age
- Treatment with systemic antineoplastic or immunomodulatory (including suprafisiológicas doses of steroids and radiotherapy) 6 months before the first dose of treatment.
- Treatment with any investigational drug 6 weeks before the first dose of treatment.
Show all 24Show fewer
- History or other evidence of any pathology associated with chronic liver disease than HCV.
- Signs or symptoms of hepatocellular carcinoma.
- History or other evidence of bleeding due to esophageal varices or other conditions consistent with decompensated liver disease.
- neutrophil count <1500 células/mm3 or platelet count <90,000 células/mm3 at Screening.
- Hb <12 g / dL in women or <13 g / dL in men, at the time of evaluation.
- Patients with baseline increased risk of anemia (eg thalassemia, spherocytosis, history of gastrointestinal bleeding, etc.). Or where the presence of anemia would be a medical problem.
- Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be treated if in the opinion of the investigator, could not tolerate an adequately sharp decline in hemoglobin.
- serum creatinine> 1.5 times above the normal upper limit at the time of valuation.
- History of severe psychiatric illness, particularly depression. Is defined as a serious psychiatric illness requiring treatment with antidepressants or major tranquilizers in therapeutic doses required for major depression or psychosis, respectively, for at least 3 months at any time before or any of the following background: attempted suicide, hospitalization due to of psychiatric illness, or period of disability due to psychiatric illness.
- History of seizure disorder or current use of major anticonvulsants.
- History of immune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced atherosclerosis, increased organ transplant or other signs of serious disease, neoplasia, or any other condition deemed by the investigator, prevent the patient is suitable for the study.
- A history of thyroid disease poorly controlled with medications prescribed, elevated concentrations of thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestation of thyroid disease.
- Pathology involving a risk of acute renal function: dehydration (diarrhea, vomiting), fever, infectious states and / or hypotonic severe (shock, sepsis, urinary infection, neuropathy).
- Evidence of severe retinopathy (eg CMV retinitis, macular degeneration).
- Exploration programanada radiation with intravenous administration of contrast media (IVU, angiography).
- Evidence of drug use in the year prior to study.
- Consumption of alcohol.
- Inability or unwillingness to give informed consent or to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Valme
Seville, 41014
Manuel Romero-Gomez, M.D. Ph.D, +34 955015761, mromerogomez@us.es
About this study
Official title: Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II
INDICATION:
Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for hepatitis C.
Read more
OBJECTIVES:
- ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with peginterferon + ribavirin resistance.
- To know the response rate in 12 weeks
- Describe the tolerance and safety of thalidomide in combination with peginterferon and ribavirin.
DESIGN OF TEST Pilot Study:
The single arm study will:
- Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) + ribavirin (based on weight: 1000-1200mg / day)
Be tracked for 24 weeks after treatment.
Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.
Patients who have been suspended for any reason, the treatment will be followed during 24 weeks, to assess safety parameters.
SUBJECT NUMBER: 10
- Conditions
- Hepatitis C
- Being tested
- thalidomide
- Keywords
- Thalidomide, Hepatitis C, Interferon resistance, Immunomodulators
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Also called thalidomide adding to peginterferon + ribavirin
Open-label pilot study analyzing the impact of adding thalidomide (200 mg/d)to SOC on 12 weeks virological response in patients with chronic hepatitis C and interferon resistance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | thalidomide added to peg-interferon + ribavirina Receives: Drug: thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological response at week 12
Measured: 36 months
Secondary outcomes (2)
Sustained virological response 24 weeks after the end of therapy
Measured: 36 months
Safety of using thalidomide together with SOC.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2012 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville
- Investigators
- Manuel Romero-Gomez, Prof., Principal investigator, Valme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856804
- Sponsor's protocol ID
- TRITAL
- Acronym
- TRITAL
- Status last verified
- Mar 2009
- First submitted
- 3 Mar 2009
- Last updated
- 6 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Adding Thalidomide to Peginterferon and Ribavirin in Patients With Hepatitis C and Resistance to Interferon. Phase II
- ClinicalTrials.gov ID
- NCT00856804
- Acronym / sponsor ID
- TRITAL / TRITAL
- Conditions
- Hepatitis C
- Keywords
- Thalidomide, Hepatitis C, Interferon resistance, Immunomodulators
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Valme University HospitalUniversity, hospital or other
- Collaborators
- University of Seville
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 6 Mar 2009 (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.
INDICATION:
Patients with chronic hepatitis C, genotype 1 and non-responders to standard treatment for hepatitis C.
OBJECTIVES:
- ascertain the rate of sustained response in patients with hepatitis C, genotype 1 with peginterferon + ribavirin resistance.
- To know the response rate in 12 weeks
- Describe the tolerance and safety of thalidomide in combination with peginterferon and ribavirin.
DESIGN OF TEST Pilot Study:
The single arm study will:
- Thalidomide 200 mg and peg-interferon alfa 2b (based on weight: 50-120 mcg / week) + ribavirin (based on weight: 1000-1200mg / day)
Be tracked for 24 weeks after treatment.
Suspended treatment of 12 weeks in patients who have failed a drop of HCV RNA> 2 log.
Patients who have been suspended for any reason, the treatment will be followed during 24 weeks, to assess safety parameters.
SUBJECT NUMBER: 10
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: thalidomidethalidomide added to peg-interferon + ribavirina |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women in non fertile age.
- HCV RNA detectable in serum.
- Chronic hepatitis C virus with non-cirrhotic compensated liver disease (clinical classification according to Child-Pugh Grade A) (Appendix 1).
- Genotype 1.
- Not responding to treatment with peginterferon alfa-2a in combination with Ribavirin.
Key exclusion criteria (24 listed)
- Patients with liver biopsy compatible with cirrhosis F4 Metav classification.
- Patients diagnosed with diabetes or basal glycemia higher than 126 mg / dl
- Women and men of childbearing age
- Treatment with systemic antineoplastic or immunomodulatory (including suprafisiológicas doses of steroids and radiotherapy) 6 months before the first dose of treatment.
- Treatment with any investigational drug 6 weeks before the first dose of treatment.
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 |
|---|---|---|
| thalidomideAlso: thalidomide adding to peginterferon + ribavirinOpen-label pilot study analyzing the impact of adding thalidomide (200 mg/d)to SOC on 12 weeks virological response in patients with chronic hepatitis C and interferon resistance. | Drug | 1 |
Primary outcome
Virological response at week 12
Time frame: 36 months
2 secondary outcomes
Sustained virological response 24 weeks after the end of therapy
Time frame: 36 months
Safety of using thalidomide together with SOC.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2009.
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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.
Manuel Romero-Gomez, Prof. principal investigator
Valme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing thalidomide in people with Hepatitis C, run by Valme University Hospital at 1 site 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 24 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: status not confirmed, as of the sponsor's last update on 6 Mar 2009. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Romero-Gomez, M.D.Ph.D (+34 955 015761, mromerogomez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virological response at week 12 (time frame: 36 months). 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 6 Mar 2009.