CirrhosisPhase 3PENTOCIRNCT00162552
Clinical Trial of Pentoxifylline in Patient With Cirrhosis
A Phase 3 study testing pentoxifylline in people with Cirrhosis and Liver Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver Failure
- What is being tested?
- pentoxifylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2004to Dec 2007
- Phase
- Phase 3
- 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
Who may be able to join
- adult patient of more than 18 years
- child pugh C cirrhosis
Who cannot join
- pregnant woman
- Patient received anticoagulant
- Patient treated for arterial hypertension
- Patient with severe coronaropathy
- Patient with hyper sensibility of pentoxifylline
- Patient hospitalized for less 24 hours
Show all 12Show fewer
- Patient admitted for a treatment of hepatocellular-carcinoma or COLLANGIO- carcinoma
- Patient with HIV
- Patient who has been transplanted
- Patient treated with immuno- suppressors
- Patient who has already received pentoxifylline for 3 months before inclusion
- Patient for whom the follow-up is considered impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure
In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
Read the detailed description
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
- Conditions
- Cirrhosis, Liver Failure
- Being tested
- pentoxifylline, PLACEBO
- Keywords
- multicenter-randomized-trial, pentoxifyllinE, placebo, cirrhosis, liver failure, cytokine
- Medical subject headings
- Fibrosis, Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentoxifyllineDrug
Patients with severe cirrhosis treated with Pentoxifylline
PLACEBODrug
Patients with severe cirrhosis treated with a placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients with severe cirrhosis treated with Pentoxifylline Receives: Drug: pentoxifylline |
| 2 | Placebo comparator | Patients with severe cirrhosis treated with a placebo Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate at 2 months
Measured: at 2 months
Secondary outcomes (5)
- survival rate at 6 months
Measured: at six months
- Number of patient with liver transplantation
Measured: during the study
- Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding
Measured: during the study
- Fibrotest and Acutest before, at 2 months and at 6 months
Measured: at 2 months and at 6 months
- TNF alpha and IL6 plasma concentration before, at 2 months and at 6 months as predictive factor of mortality
Measured: at 2 months and at 6 months as predictive factor of mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Didier LEBREC, MD, Principal investigator, hopital Beaujon, APHP, france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162552
- Sponsor's protocol ID
- P030439
- Other IDs
- AOM03120
- Acronym
- PENTOCIR
- Status last verified
- Aug 2005
- First submitted
- 9 Sep 2005
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lebrec D, Thabut D, Oberti F, Perarnau JM, Condat B, Barraud H, Saliba F, Carbonell N, Renard P, Ramond MJ, Moreau R, Poynard T; Pentocir Group. Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis. Gastroenterology. 2010 May;138(5):1755-62. doi: 10.1053/j.gastro.2010.01.040. Epub 2010 Jan 25.
PubMed 20102716
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure
- ClinicalTrials.gov ID
- NCT00162552
- Acronym / sponsor ID
- PENTOCIR / P030439
- Conditions
- Cirrhosis, Liver Failure
- Keywords
- multicenter-randomized-trial, pentoxifyllinE, placebo, cirrhosis, liver failure, cytokine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Sep 2005 (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 patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
Detailed description
The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.
All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: pentoxifyllinePatients with severe cirrhosis treated with Pentoxifylline |
| 2 | Placebo comparator | Drug: PLACEBOPatients with severe cirrhosis treated with a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patient of more than 18 years
- child pugh C cirrhosis
Key exclusion criteria (12 listed)
- pregnant woman
- Patient received anticoagulant
- Patient treated for arterial hypertension
- Patient with severe coronaropathy
- Patient with hyper sensibility of pentoxifylline
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 |
|---|---|---|
| pentoxifyllinePatients with severe cirrhosis treated with Pentoxifylline | Drug | 1 |
| PLACEBOPatients with severe cirrhosis treated with a placebo | Drug | 2 |
Primary outcome
survival rate at 2 months
Time frame: at 2 months
5 secondary outcomes
- survival rate at 6 months
Time frame: at six months
- Number of patient with liver transplantation
Time frame: during the study
- Complications : bacterial infection, renal insufficiency, hepatic encephalopathy, gastrointestinal bleeding
Time frame: during the study
- Fibrotest and Acutest before, at 2 months and at 6 months
Time frame: at 2 months and at 6 months
- TNF alpha and IL6 plasma concentration before, at 2 months and at 6 months as predictive factor of mortality
Time frame: at 2 months and at 6 months as predictive factor of mortality
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 17 Jan 2008.
- Derived from this study: PubMed 20102716Lebrec D, Thabut D, Oberti F, Perarnau JM, Condat B, Barraud H, Saliba F, Carbonell N, Renard P, Ramond MJ, Moreau R, Poynard T; Pentocir Group. Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis. Gastroenterology. 2010 May;138(5):1755-62. doi: 10.1053/j.gastro.2010.01.040. Epub 2010 Jan 25.
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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.
Didier LEBREC, MD principal investigator
hopital Beaujon, APHP, france
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pentoxifylline in people with Cirrhosis and Liver Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 12 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 17 Jan 2008. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
survival rate at 2 months (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00162552, which also lists 1 linked publication.
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 17 Jan 2008.