Fetal Hemoglobin Induction Treatment Metformin

NCT02981329

Last updated date
Study Location
Texas Children's Hospital
Houston, Texas, 77030, United States
Contact
832-824-4459

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Anemia, Sickle Cell Disease, Hemoglobin Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Confirmed diagnosis of sickle cell anemia

2. Age greater than or equal to 10 and less than or equal to 60 years of age.

3. If on hydroxyurea, fetal hemoglobin less than 20% at a stable dose (mg/kg) determined by the primary hematology provider over at least four months.

4. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2

5. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Failure to meet inclusion criteria


2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA
level greater than 5% in SCA patients


3. Refusal to use medically effective birth control if female and sexually active.


4. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months
(temporary exclusion).


5. Creatinine greater than 1.4mg/dL


6. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits
of normal.

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Sickle Cell Anemia, Sickle Cell Disease, Hemoglobin DisorderFetal Hemoglobin Induction Treatment Metformin
NCT02981329
  1. Houston, Texas
  2. Houston, Texas
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Fetal Hemoglobin Induction Treatment Metformin
Official Title  ICMJE Use of Metformin as a Fetal Hemoglobin Inducer in Patients With Hemoglobinopathies
Brief Summary The purpose of this study is to determine whether metformin is effective in the treatment for sickle cell anemia (SCA).
Detailed Description This is a dose escalation, pilot study for subjects with sickle cell anemia (SCA) disease to determine if metformin has a beneficial effect on the treatment and quality of life of SCA patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Anemia
  • Sickle Cell Disease
  • Hemoglobin Disorder
Intervention  ICMJE
  • Drug: Metformin
    Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.
    Other Names:
    • Glucophage
    • Riomet,
  • Behavioral: Questionnaires
    Questionnaires will be completed to assess the impact quality of life
Study Arms  ICMJE
  • Experimental: Group A: Hydroxyurea + Metformin
    Subjects who are currently taking Hydroxyurea as part of standard of care and have sickle cell anemia.
    Interventions:
    • Drug: Metformin
    • Behavioral: Questionnaires
  • Experimental: Group B: Metformin (Group B has closed to enrollment)
    Subjects who are not taking Hydroxyurea as part of standard of care and have sickle cell anemia.
    Interventions:
    • Drug: Metformin
    • Behavioral: Questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 17, 2020)
56
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2016)
37
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed diagnosis of sickle cell anemia
  2. Age greater than or equal to 10 and less than or equal to 60 years of age.
  3. If on hydroxyurea, fetal hemoglobin less than 20% at a stable dose (mg/kg) determined by the primary hematology provider over at least four months.
  4. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2
  5. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.

Exclusion Criteria:

  1. Failure to meet inclusion criteria
  2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA level greater than 5% in SCA patients
  3. Refusal to use medically effective birth control if female and sexually active.
  4. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months (temporary exclusion).
  5. Creatinine greater than 1.4mg/dL
  6. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits of normal.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vivien Sheehan, MD832-824-4459[email protected]
Contact: Chukwuma Kalu[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981329
Other Study ID Numbers  ICMJE H-38457 Metformin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:The leftover blood samples for genetic analysis will be banked indefinitely for future ancillary studies. Investigator who desires access to these samples must present their research idea prior to receiving access to the samples. The samples will be shared with researchers affiliated with Texas Children's Hospital, Baylor College of Medicine and/or other hematology collaborators for future studies associated with hematologic diseases and drugs used to treat such diseases. The recipient investigators are required to provide proof of IRB approval or exemption as per local IRB guidelines before the sample can be released for research purposes. After receipt of IRB approval, coded samples will be distributed to the recipient investigator.
Responsible Party Vivien Sheehan, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Vivien Sheehan, MDBaylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP