Anemia, Sickle CellPhase 2NCT00029731
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
A Phase 2 study testing Arginine hydrochloride in people with Anemia, Sickle Cell and Pneumonia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Anemia, Sickle Cell, Pneumonia
- What is being tested?
- Arginine hydrochloride
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Jul 2005
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)
- Acute chest syndrome with the following:
- New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
- Fever
- Cough, tachypnea, retractions, rales, or wheezing
- Chest pain
Who cannot join
- Inability to take or tolerate oral medications
- Hepatic dysfunction (SGPT greater than 2 times normal)
- Renal dysfunction (creatinine greater than 2 times normal)
- Mental status or neurological changes
- Allergy to arginine
- History of priapism
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Oakland
Oakland, California, 94609
About this study
Official title: Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.
Read the detailed description
Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Anemia, Sickle Cell, Pneumonia
- Being tested
- Arginine hydrochloride
- Keywords
- Nitric Oxide, Administration, Oral
- Medical subject headings
- Anemia, Sickle Cell, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2002 (estimated)
- Study startAug 2001
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies 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
- Parallel groups
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029731
- Sponsor's protocol ID
- FD-R-1978-01
- Other IDs
- FD-R-001978-01
- Status last verified
- Jan 2002
- First submitted
- 21 Jan 2002
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00029731
- Acronym / sponsor ID
- FD-R-1978-01
- Conditions
- Anemia, Sickle Cell, Pneumonia
- Keywords
- Nitric Oxide, Administration, Oral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Jul 2005
- First posted
- 22 Jan 2002 (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.
This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.
Detailed description
Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)
- New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
- Fever
- Cough, tachypnea, retractions, rales, or wheezing
- Chest pain
Key exclusion criteria (7 listed)
- Inability to take or tolerate oral medications
- Hepatic dysfunction (SGPT greater than 2 times normal)
- Renal dysfunction (creatinine greater than 2 times normal)
- Mental status or neurological changes
- Allergy to arginine
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 |
|---|---|---|
| Arginine hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arginine hydrochloride in people with Anemia, Sickle Cell and Pneumonia, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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 7 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 25 Mar 2015. 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 United States. 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?
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.
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 25 Mar 2015.