Phase 4 Sickle Cell Disease Trial, Completed NCT00171301 Sponsor: Novartis Pharmaceuticals Condition: Sickle Cell Disease
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called deferasirox, which is used to remove excess iron from the body (a condition that can build up in people who need regular blood transfusions). A total of 233 people took part — 162 children aged between 2 and under 16 years, and 71 people aged 16 or older. The trial ran in two parts: a core study followed by an extension period. The main things being measured were changes in the amount of iron stored in the liver, and changes in a blood marker called serum ferritin (a protein that reflects how much iron is stored in the body overall). The reported data shows that, when looking at whether participants met the pre-set targets for reducing or maintaining their liver iron levels, 76.6% of the younger age group and 73.8% of the older age group were recorded as meeting those targets by the end of the extension study (these figures relate to participants who started with the highest iron levels). For those who started with moderately raised liver iron levels, the reported success rate was 72.2% in the younger group and 50.0% in the older group. For participants who started with lower liver iron levels, 75% of the younger group met their target; the corresponding figure for the older group was not reported in the data. In terms of the actual change in liver iron, the reported data shows an average decrease of around 9 mg Fe/g dw in the younger group and around 8.4 mg Fe/g dw in the older group among those who started with higher iron levels. Changes in the serum ferritin blood marker were also reported: the younger group showed an average decrease of approximately 1,433 µg/L and the older group approximately 1,792 µg/L over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Sickle Cell Disease Trial, Completed

NCT00171301
Completed Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You must have already completed the full 12-month main study (NCT00171171).
  • Female patients who have had their first period and are sexually active must be using an effective form of birth control, or must have had a procedure such as removal of the uterus and/or ovaries, or tubal ligation.
  • You (and/or your legal guardian, if applicable) must have signed a consent form agreeing to take part, following the rules of your country.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You cannot join if you are currently pregnant or breastfeeding.
  • You may not be able to join if the trial doctor feels you may have difficulty following the study rules or cooperating with the study requirements (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 August 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Completed
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 June 2005
Est. completion
1 May 2008

Where this trial was run

🇪🇬 Egypt 🇱🇧 Lebanon Oman 🇸🇦 Saudi Arabia Syria

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Percentage of Participants With Treatment Success From Core Baseline (BL) to Extension End of Study, by Baseline LIC Level and Age; Absolute Change in Liver Iron Concentration (LIC)Measured by Liver MRI or Liver Biopsy From Core Study Baseline (BL) to End of Extension Study, by LIC Category

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov