Liver Failure, AcuteG-CSFNCT01341951
Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
A study testing Granulocyte colony stimulating factor in people with Liver Failure, Acute, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Acute
- What is being tested?
- Granulocyte colony stimulating factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Jun 2011
- Phase
- Interventional
- 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
- Patients with Acute Liver failure as defined by AASLD.65
- Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but <300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.
Who cannot join
- Known hypersensitivity to filgrastim
- creatinine > 150 µmol/L
- infection or hemorrhage within the last 10 days
- documented hepatocellular carcinoma
- hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education & Research Chandigarh India
Chandigarh, Chandigarh, 1600012
Arun Sharma, DM, 08872721666, drarunvashisht@yahoo.co.in
Arun Sharma, DM Hepatology
About this study
Official title: G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
Read the detailed description
In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.
- Conditions
- Liver Failure, Acute
- Being tested
- Granulocyte colony stimulating factor
- Keywords
- liver failure, Acute
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte colony stimulating factorDrug
300 I.U twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| G-CSF therapy in acute liver failure and alcoholic hepatitis | Experimental | G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis Receives: Drug: Granulocyte colony stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
Measured: 1 year
Secondary outcomes (1)
clinical and biochemical improvement in liver functions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
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 Liver Failure, AcuteStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- virendra singh, Principal investigator, Postgraduate Institute of Medical Education and Research Chandigarh India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341951
- Sponsor's protocol ID
- PIMERIndia
- Acronym
- G-CSF
- Status last verified
- Jan 2011
- First submitted
- 15 Apr 2011
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
PubMed 18537187
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
- ClinicalTrials.gov ID
- NCT01341951
- Acronym / sponsor ID
- G-CSF / PIMERIndia
- Conditions
- Liver Failure, Acute
- Keywords
- liver failure, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 26 Apr 2011 (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.
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
Detailed description
In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-CSF therapy in acute liver failure and alcoholic hepatitis | Experimental | Drug: Granulocyte colony stimulating factorG-CSF therapy given in cases with acute liver failure and alcoholic hepatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Acute Liver failure as defined by AASLD.65
- Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but <300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.
Key exclusion criteria (5 listed)
- Known hypersensitivity to filgrastim
- creatinine > 150 µmol/L
- infection or hemorrhage within the last 10 days
- documented hepatocellular carcinoma
- hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy
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 |
|---|---|---|
| Granulocyte colony stimulating factor300 I.U twice daily for 5 days | Drug | G-CSF therapy in acute liver failure and alcoholic hepatitis |
Primary outcome
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
Time frame: 1 year
1 secondary outcome
clinical and biochemical improvement in liver functions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- Background: PubMed 18537187Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
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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.
virendra singh principal investigator
Postgraduate Institute of Medical Education and Research Chandigarh India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Granulocyte colony stimulating factor in people with Liver Failure, Acute, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 5 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 26 Apr 2011. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arun Sharma, DM (08872721666, drarunvashisht@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization (time frame: 1 year). 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 NCT01341951, 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 26 Apr 2011.