Beta Thalassemia Major Anemia Clinical Trial
Official title:
The Potential Hepatoprotective Effect of Metformin in Patients With Beta Thalasemia Major
NCT number | NCT02984475 |
Other study ID # | CL 1726 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | April 2019 |
Verified date | July 2018 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Beta Thalassemia is a major public health problem in Mediterranean countries.In Egypt, it is
considered as the most common chronic hemolytic anemia.one of the major complications in this
inherited disorder is iron overload which lead to oxidative stress and tissue damage.
Regarding toxic effect of iron overload on liver, hepatomegaly is one of the most findings
that resulting from hemosiderosis, extra medullary hematopoiesis, transmitted hepatitis B and
C and cirrhosis.
A lot of studies have been carried out recently to study the beneficial role of metformin in
non-diabetic patients of different disorders as non-alcoholic fatty liver disease
(NAFLD).Among several studies, it's demonstrated that metformin significantly improved
insulin resistance, aminotransferase levels and liver morphology.
The role of metformin in these studies is mainly thought to be antioxidant and
anti-inflammatory effects. However, the role of Metformin on hepatic function in different
populations with the same mechanism of liver injury should be further investigated.
This clinical trial will be carried out on 60 patients with beta thalassemia major receiving
regular blood transfusion and iron chelating therapy, either HCV positive or negative
patients.
They will be randomly distributed into either control group (group 1, n=30) receiving blood
transfusion and taking iron chelating therapy or treatment group (group 2, n=30) receiving
blood transfusion and taking iron chelating therapy along with metformin tablets (500
mg/twice daily) for 6 months.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with Beta-Thalassemia Major and receiving regular blood transfusion and on iron chelating therapy. - Weight: equal to or over 35 kg. - Normal renal function. Exclusion Criteria: - Patients with renal impairment (serum creatinine more than twice the upper limit of normal). - Patients with heart failure. - Patients with sepsis or active infection. - Patients with diabetes mellitus (either primary or secondary to thalassemia). - regular consumption of medication with potential hepatotoxicity. - regular herbal medicine or antioxidant supplementation. - patients with gastrointestinal conditions preventing adsorption of oral medication. |
Country | Name | City | State |
---|---|---|---|
Egypt | Abo El Reesh Hospital | Cairo. | |
Egypt | El Demerdash (Ain Shams Teaching Hospital). | Cairo. |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fibroscan. | Fibroscan will be done for each patient before and at the end of the study. | 6 months | |
Other | FIB 4 score. | Fibrosis 4 score. | 6 months | |
Other | APRI score. | AST to platelet ratio index score. | 6 months | |
Primary | liver enzymes tests. | Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST). | 6 months | |
Secondary | Metformin Safety - Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 months | |
Secondary | liver enzymes and function tests - Alkaline phosphatase (ALP). | Alkaline phosphatase (ALP). | 6 months. | |
Secondary | liver enzymes and function tests - Gama-Glutamyl transferase (GGT). | Gama-Glutamyl transferase (GGT). | 6 months. | |
Secondary | liver enzymes and function tests - total and direct bilirubin. | total and direct bilirubin. | 6 months. | |
Secondary | liver enzymes and function tests - Albumin. | Albumin . | 6 months. | |
Secondary | liver enzymes and function tests - International Normalized Ratio (INR). | International Normalized Ratio (INR). | 6 months. | |
Secondary | oxidative stress markers (MDA). | Malondialdehyde (MDA) | 6 months. | |
Secondary | oxidative stress markers (TAC). | Total antioxidant capacity (TAC). | 6 months. |
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