This service will be redeveloped soon — your feedback will help us to improve it.

Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients Wit... | Recruiting
Long-term Safety and Efficacy of Fe... | Recruiting
Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias

Location not identified by Google services

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Iron Overload
  • Sickle Cell Disease
  • Other Anemias
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Recruiting
Trial source and source ID number
NCT02443545
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more information about the safety and efficacy of deferiprone in patients with sickle cell disease or other anemias who suffer from iron overload caused by regular blood transfusions.
Research Details
  • Deferiprone (brand name Ferriprox®) is an iron chelator that is approved in the United States and over 60 other countries for the treatment of iron overload in patients with thalassemia, when other treatments are inadequate. This study has been designed to evaluate the long-term efficacy, safety, and tolerability of deferiprone to treat iron overload in patients who have sickle cell disease or other anemias.

    Only patients who have completed an earlier study, LA38-0411, are eligible to enroll in this one.
Phase
Phase 4
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Deferiprone

Study Arm Groups : Group 1: Deferiprone 3 years, Group 2: Deferiprone 2 years

Intervention Type
See Interventions above
Primary Outcome Measures
    Number of subjects with adverse events (AEs); From the first day of the study until the last study visit (Week 104 or early termination); Number of subjects with serious adverse events (SAEs); From the first day of the study until 30 days after the last dose; Discontinuations due to adverse events; From the first day of the study until Week 104
Secondary Outcome Measures
    Change from baseline to end of study in liver iron concentration (LIC); Group 1: From Week 0 of study LA38-0411 until the last visit of study LA38-EXT (Week 104 or early termination). Group 2: From Week 0 of study LA38-EXT until the last visit (Week 104 or early termination).; Change from baseline to end of study in cardiac MRI T2*; Group 1: From Week 0 of study LA38-0411 until the last visit of study LA38-EXT (Week 104 or early termination). Group 2: From Week 0 of study LA38-EXT until the last visit (Week 104 or early termination).; Change from baseline to end of study in serum ferritin; Group 1: From Week 0 of study LA38-0411 until the last visit of study LA38-EXT (Week 104 or early termination). Group 2: From Week 0 of study LA38-EXT until the last visit (Week 104 or early termination).; Responder analysis; Group 1: From Week 0 of study LA38-0411 to Weeks 0, 52, and 104 of LA38-EXT (1, 2, and 3 years of deferiprone treatment, respectively). Group 2: From Week 0 of study LA38-EXT to Weeks 52 and 104 (1 and 2 years of deferiprone treatment, respectively).
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
3 Years - N/A
Who Can Participate
Patients
Number of Participants
300
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Completed study LA38-0411

    2. Females of childbearing potential must have a negative pregnancy test result at Visit 1. In addition, if applicable, they must:

    - Use an effective method of contraception according to local requirements, during the study and within 30 days following their last dose of study medication, OR

    - Have had a tubal ligation (supporting evidence required), OR

    - Have had a hysterectomy (supporting evidence required), OR

    - Participate in a non-heterosexual lifestyle, OR

    - Have a male sexual partner who has been sterilized (supporting evidence required)

    3. Fertile heterosexual males and/or their partners must agree to use an effective method of contraception during the study and for 30 days following the last dose of study medication

    4. All patients and/or their authorized legal representatives must provide signed and dated written informed consent prior to the first study intervention, and assent will be obtained from patients who are considered to be minors. Patients must be able to adhere to study restrictions, appointments, and evaluation schedules.

    Exclusion Criteria:

    1. Plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study

    2. For only those patients who were treated with deferoxamine in study LA38-0411 (Group 2): Presence of any medical condition (including clinically significant laboratory abnormalities, such as ALT ≥ 5 x ULN or creatinine ≥ 2 x ULN), psychological condition, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise.

    3. Pregnant, breastfeeding, or planning to become pregnant during the study period.

    4. Treatment failure after 1 year on deferiprone which in the investigator's judgment indicates the need for the patient to be started on a different iron chelator
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, Egypt, Saudi Arabia, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Long-term Safety and Efficacy Study of Ferriprox® for the Treatment of Transfusional Iron Overload in Patients With Sickle Cell Disease or Other Anemias
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
LA38-EXT
Sponsor(s)
ApoPharma
Key Dates

Recruitment Start Date

May 2015

Recruitment End Date

Oct 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 May 2015

Date updated in source

10 Jan 2019