Beta ThalassemiaPhase 3NAC/ALANCT07157722
Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia
A Phase 3 study testing Iron chelating intervention, N Acetyl cysteine 600mg and Alpha Lipoic Acid 600 MG Oral Tablets in people with Beta Thalassemia, run by Tanta University at 1 site in Egypt.
Trial summary
The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Beta Thalassemia
- What is being tested?
- Iron chelating intervention, N Acetyl cysteine 600mg and Alpha Lipoic Acid 600 MG Oral Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 30 Jan 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with beta-thalassemia who will receive conventional thalassemia management.
- Both genders.
- Age ≥ 18 years old.
Who cannot join
- Patients with familial hypercholesterolemia or history of premature atherosclerosis.
- Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.
- Patients with severe renal dysfunction.
- Patients with severe hepatic dysfunction.
- Patients with diabetes.
- Patients who will be non-compliant with the prescribed therapy.
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- Patients with other hemoglobinopathies.
- Pregnant women.
- Obese patients.
- Patients who will receive antioxidant or anti-inflammatory medications.
- Patients with inflammatory diseases, such as Systemic lupus erythematous, rheumatoid arthritis and inflammatory bowel disease.
- Patients with oxidative stress related diseases, such as Alzheimer, Parkinson, COPD and cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Pharmacy - Tanta University
Tanta, 31511
Mahmoud M Elkholy, Teaching Assistant, 0020102397742 ext. 002, mahmoud.m_elkholy@yahoo.com
Mahmoud M Elkholy, Master
About this study
Official title: The Potential Role of N-Acetyl Cysteine or Alpha-Lipoic Acid as Adjuvant Therapies in the Treatment of Patients With Beta Thalassemia
The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.
Read the detailed description
Beta-thalassemia (β-thalassemia) is a hereditary blood disorder, which is characterized by a genetic disorder in the production of β-globin chains. β-thalassemia is inherited mainly by an autosomal recessive manner resulting in reduced synthesis or absence of β-globin chains, leading to ineffective erythropoiesis and chronic hemolytic anemia. It is classified according to the severity into major, intermedia and minor.
This is a randomized, parallel, clinical study that will be conducted on sixty-six patients with beta-thalassemia. The study duration will be 12 weeks. Patients will be divided into three groups as follows:
Group I (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
Group II (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months.
Group III (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months.
The study will be approved by the Research Ethical Committee at Faculty of Pharmacy, Tanta University. All participants will be informed about benefits and risks of the study. The privacy of all participants will be respected and the data of enrolled participants will be confidential. All participants will sign their written informed consent.
- Conditions
- Beta Thalassemia
- Being tested
- Iron chelating intervention, N Acetyl cysteine 600mg, Alpha Lipoic Acid 600 MG Oral Tablets
- Keywords
- NAC, ALA
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron chelating interventionDrug
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.
N Acetyl cysteine 600mgDrug
N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.
Alpha Lipoic Acid 600 MG Oral TabletsDrug
Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: (Iron chelating agent group) | Active comparator | Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. Receives: Drug: Iron chelating intervention |
| Group 2: (Iron chelating agent + NAC group) | Active comparator | Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks. Receives: Drug: Iron chelating intervention; Drug: N Acetyl cysteine 600mg |
| Group 3: (Iron chelating agent + ALA group) | Active comparator | Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks. Receives: Drug: Iron chelating intervention; Drug: Alpha Lipoic Acid 600 MG Oral Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in carotid intima media thickness (CIMT)
Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness
Measured: 3 months
Secondary outcomes (4)
Change in Malondialdehyde (MDA)
Malondialdehyde (MDA) level will be assessed using commercially available kit
Measured: 3 months
Change in high sensitivity C-reactive protein (hs-CRP)
High sensitivity C-reactive protein (hs-CRP) level will be assessed using commercially available kit.
Measured: 3 months
Change in asymmetric dimethyl arginine (ADMA)
Asymmetric dimethyl arginine (ADMA) level will be assessed using commercially available kit.
Measured: 3 months
Change in lipid profile
HDL, total cholesterol and triglycerides will be assessed using commercially available kits.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start30 Aug 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta ThalassemiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel, clinical study that will be conducted on 66 patients with beta-thalassemia who fulfill the selection criteria and will be classified randomly into 3 groups as follows: Group I (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. Group II (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months. Group III (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Elkholy, Tanta University
- Investigators
- Sahar M El-Haggar, Professor, Study director, Tanta UniversityTarek M Mostafa, Professor, Study director, Tanta UniversityBasma A Mansour, Lecturer, Study director, Faculty of Medicine - Mansoura UniversityMohammed A El hawary, Assistant Professor, Principal investigator, Faculty of Medicine - Mansoura UniversityMahmoud M Elkholy, Teaching Assistant, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157722
- Sponsor's protocol ID
- 9250572
- Acronym
- NAC/ALA
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of N-Acetyl Cysteine or Alpha-Lipoic Acid as Adjuvant Therapies in the Treatment of Patients With Beta Thalassemia
- ClinicalTrials.gov ID
- NCT07157722
- Acronym / sponsor ID
- NAC/ALA / 9250572
- Conditions
- Beta Thalassemia
- Keywords
- NAC, ALA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- 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 current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.
Detailed description
Beta-thalassemia (β-thalassemia) is a hereditary blood disorder, which is characterized by a genetic disorder in the production of β-globin chains. β-thalassemia is inherited mainly by an autosomal recessive manner resulting in reduced synthesis or absence of β-globin chains, leading to ineffective erythropoiesis and chronic hemolytic anemia. It is classified according to the severity into major, intermedia and minor.
This is a randomized, parallel, clinical study that will be conducted on sixty-six patients with beta-thalassemia. The study duration will be 12 weeks. Patients will be divided into three groups as follows:
Group I (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
Group II (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months.
Group III (n = 22):
This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months.
The study will be approved by the Research Ethical Committee at Faculty of Pharmacy, Tanta University. All participants will be informed about benefits and risks of the study. The privacy of all participants will be respected and the data of enrolled participants will be confidential. All participants will sign their written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a randomized, parallel, clinical study that will be conducted on 66 patients with beta-thalassemia who fulfill the selection criteria and will be classified randomly into 3 groups as follows: Group I (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. Group II (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months. Group III (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months.
| Arm | Type | Receives |
|---|---|---|
| Group 1: (Iron chelating agent group) | Active comparator | Drug: Iron chelating interventionPatients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. |
| Group 2: (Iron chelating agent + NAC group) | Active comparator | Drug: Iron chelating intervention, Drug: N Acetyl cysteine 600mgPatients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks. |
| Group 3: (Iron chelating agent + ALA group) | Active comparator | Drug: Iron chelating intervention, Drug: Alpha Lipoic Acid 600 MG Oral TabletsPatients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with beta-thalassemia who will receive conventional thalassemia management.
- Both genders.
- Age ≥ 18 years old.
Key exclusion criteria (12 listed)
- Patients with familial hypercholesterolemia or history of premature atherosclerosis.
- Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.
- Patients with severe renal dysfunction.
- Patients with severe hepatic dysfunction.
- Patients with diabetes.
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 |
|---|---|---|
| Iron chelating interventionJADENU is indicated for the treatment of chronic iron overload due to blood transfusions. | Drug | Group 1: (Iron chelating agent group), Group 2: (Iron chelating agent + NAC group), Group 3: (Iron chelating agent + ALA group) |
| N Acetyl cysteine 600mgN-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks. | Drug | Group 2: (Iron chelating agent + NAC group) |
| Alpha Lipoic Acid 600 MG Oral TabletsAlpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks. | Drug | Group 3: (Iron chelating agent + ALA group) |
Primary outcome
The change from baseline in carotid intima media thickness (CIMT)
Time frame: 3 months
Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness
4 secondary outcomes
Change in Malondialdehyde (MDA)
Time frame: 3 months
Change in high sensitivity C-reactive protein (hs-CRP)
Time frame: 3 months
Change in asymmetric dimethyl arginine (ADMA)
Time frame: 3 months
Change in lipid profile
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
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Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
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Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
Sahar M El-Haggar, Professor study director
Tanta University
Tarek M Mostafa, Professor study director
Tanta University
Basma A Mansour, Lecturer study director
Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron chelating intervention, N Acetyl cysteine 600mg and Alpha Lipoic Acid 600 MG Oral Tablets in people with Beta Thalassemia, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Sep 2025. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Elkholy, Master (01023997742, mahmoud.m_elkholy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in carotid intima media thickness (CIMT) (time frame: 3 months). 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 5 Sep 2025.