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Thalassemia MajorPhase 1NCT05777733

NAC Effect on Iron Overload and Blood Transfusion in β-thalassemia Major

A Phase 1 study testing n-acetylcystine in people with Thalassemia Major, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The effect of N_acetylcystein as an antioxidant on iron overload and frequency of blood transfusion in β-thalassemia major patients at Assiut Childern Hospital University And its cosubmitted for partial fulfillment of master degree in Pediatrics Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Thalassemia Major
What is being tested?
n-acetylcystine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
23 Mar 2024to 30 Apr 2024
Phase
Phase 1
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 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • thalassemia major children .
  • On oral iron chelation .

Who cannot join

  • change in the dose of iron chelation within 3 months before enrollement or during study period .
  • Liver impairment
  • Renal impairment
  • patients not adeherent to therapy

About this study

Official title: The Effect of N_acetylcystein as an Antioxidant on Iron Overload and Frequency of Blood Transfusion in β-thalassemia Major Patients at Assiut Childern Hospital University

The effect of N_acetylcystein as an antioxidant on iron overload and frequency of blood transfusion in β-thalassemia major patients at Assiut Childern Hospital University And its cosubmitted for partial fulfillment of master degree in Pediatrics

Read the detailed description

Beta thalassemia major it menifests after 6 months of life by severe anemia requiring life-long blood transfusion,which is the the gold standard therapy causing many complications including iron overload which associated to a certain extent with the generation of labile iron in the pathological red blood cell (RBC). The appearance of such forms of iron at the inner and outer cell surfaces exposes the cell to formation of reactive oxygen species (ROS),particularly the hydroxyl radical (·OH) serving as a Fenton reagent, Hydroxyl radical facilitated by membraneassociated iron might be particularly harmful because radical generation would be relatively sequestered from the cell antioxidant capacity and occur directly adjacent to lipid and protein membrane components exceeding cellular defense capacities causing oxidtive stress with prematre cell damage which is the main pathophysiological process in thalassemia . the fact that iron plays a major role in the generation of ROS implies that iron chelators can also serve as antioxidants. Obviously, chelation of iron is one of the major therapeutic goals in thalassemia. Consequently, the orally administered iron chelator deferiprone was able to remove free iron from β- thalassemic red cell membranes in a dose-related fashion, Deferiprone alleviated membrane damage possibly mediated by catalytic iron, such as In a few patients with Hb E/β thalassemia in Thailand, following administration of deferiprone alone for an average of 50 weeks, Hb levels increased concomitant with a decrease in transfusion requirement One possible explanation for this finding is that deferiprone acted like an antioxidant by removing excess free iron from the cells and, as a result, ROS generation was decreased. However, the antioxidant effect of this iron chelator by itself was not sufficient to neutralize the damage induced by ROS Moreover, oral administration of other antioxidant such as vitamin E, which is a lipid antioxidant, exhibited improvement in oxidant-antioxidant balance in the plasma . Another antioxidant that acts primarily on proteins is n_acetylcysteine, which improved certain parameters resulting from oxidative damage to sickle RBCs. here we will give the N_acetylcysteine orally in dose 10mg\kg\day to the thalassemic patients for 6 months and observing its effect as antioxidant on iron overload and the frequency in blood transfusion The ultimate purpose of all these observations is to try to design a combination of antioxidants consisting of an iron chelator, such as deferiprone, vitamin E as antioxidant for the lipids, and N-acetylcysteine as antioxidant for the proteins to decrease the deleterious effect of ORS.

Being tested
n-acetylcystine
Keywords
N_acetylcystein antioxidant effect
Medical subject headings
beta-Thalassemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • n-acetylcystineDrug

    Also called acetylcystein

    Single daily oral administration of N_acetylcystein on dose 10mg /kg/day

Study groups in NCT05777733
Study groupRoleWhat they receive
N_acetylcystein as antioxidant on iron and frequency of blood transfusion in thalassemia majorExperimentalN_acetylcystein administration on single oral dose 10mg /kg for 6 months and it's effect on iron and frequency of blood transfusion before and after its use.
Receives: Drug: n-acetylcystine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum ferritin level

    Measuring serum ferritin level (mg/dl) before and after 6 months of acetylcystein administration.

    Measured: 6 months from the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start23 Mar 2024 (estimated)
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

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 1
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
N-acetylcystein in dose 10mg /kg single oral dose will be given for 6 months
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777733
Sponsor's protocol ID
NAC as antioxidant
Status last verified
Mar 2023
First submitted
7 Jan 2023
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mohamed YA, Meabed MH, Ashraf A, Morgan DS, Abdul Latif MG, Abd-Elkareem RM, Ahmed HM. WITHDRAWN:Randomized controlled trial of effect of N-acetylcysteine as an antioxidant on iron overload in children with thalassemia major. Clin Exp Pediatr. 2020 Nov 3. doi: 10.3345/cep.2020.00227. Online ahead of print.

    PubMed 33147909

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing n-acetylcystine in people with Thalassemia Major, run by Assiut University.

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 2 inclusion and 4 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 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum ferritin level (time frame: 6 months from the baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05777733, which also lists 1 linked publication.

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 23 Aug 2023.

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