Pulmonary Veno-Occlusive DiseaseNCT00563498
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
A study testing Glutamine in people with Pulmonary Veno-Occlusive Disease and Hepatic Veno-Occlusive Disease, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis
- What is being tested?
- Glutamine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jul 2004to Jun 2006
- 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
- Adult, Older adult
Who may be able to join
- Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
YH Leung, Dr
Raymond Liang, Prof
About this study
Official title: A Randomized Control Studies on the Effects of Glutamine on the Clinical Outcome of Bone Marrow Transplant Recipients With Special Reference to Veno-occlusive Disease and Mucositis.
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.
- Being tested
- Glutamine
- Keywords
- Veno-occlusive disease, Mucositis
- Medical subject headings
- Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Veno-occlusive disease
Measured: 1 month
Mucositis
Measured: 1 month
Secondary outcomes (2)
Hospital stay
Measured: 2 months
Use of antibiotics
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJul 2004
- Study completionJun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Veno-Occlusive DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong, Fresienius Kabi HK Ltd
- Investigators
- Albert Lie, Dr, Principal investigator, Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563498
- Sponsor's protocol ID
- EC1432-00
- Other IDs
- HARECCTR0500034
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Studies on the Effects of Glutamine on the Clinical Outcome of Bone Marrow Transplant Recipients With Special Reference to Veno-occlusive Disease and Mucositis.
- ClinicalTrials.gov ID
- NCT00563498
- Acronym / sponsor ID
- EC1432-00
- Keywords
- Veno-occlusive disease, Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong, Fresienius Kabi HK Ltd
- Study start
- Jul 2004
- Study completion
- Jun 2006 (estimated)
- First posted
- 26 Nov 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.
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Glutamine | Drug | – |
Primary outcome
Veno-occlusive disease
Time frame: 1 month
Mucositis
Time frame: 1 month
2 secondary outcomes
Hospital stay
Time frame: 2 months
Use of antibiotics
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Albert Lie, Dr principal investigator
Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine in people with Pulmonary Veno-Occlusive Disease and Hepatic Veno-Occlusive Disease, run by Hospital Authority, Hong Kong at 1 site in China.
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 1 inclusion and 0 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 7 Jul 2010. 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 China. 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 YH Leung, Dr ((852) 2855 3347, ayhleung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veno-occlusive disease (time frame: 1 month). The study lists 2 primary outcomes in all. 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 7 Jul 2010.