NCT05081349

Brief Summary

The role of the combination therapy of hydroxyurea and L-Carnitine was studied in thalassemic patients. nevertheless its role in sickle cell anemia patients was not investigated

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 22, 2021

Status Verified

December 1, 2016

Enrollment Period

3.4 years

First QC Date

September 24, 2021

Last Update Submit

October 15, 2021

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

  • Hematological(HR)

    Change of hemoglobin

    2-3 months

  • Hematological response

    Change of hematocrit

    2-3 months

Secondary Outcomes (1)

  • Frequency of painful episodes/ blood transfusions

    1-year

Other Outcomes (1)

  • Delayed effects

    12-18 months

Study Arms (4)

Hydra+L-Carnitine

EXPERIMENTAL

Hydroxycarbamide+ L-Carnitine+supportive treatment

Drug: Hydroxycarbamide 500 Mg Oral Capsule+L-Carnitine

Hydra only

ACTIVE COMPARATOR

Hydroxycarbamide+ supportive treatment

Drug: Hydroxycarbamide 500 Mg Oral Capsule

L-Carnitine only

ACTIVE COMPARATOR

L-Carnitine+ supportive treatment

Drug: L-Carnitine, 250 Mg Oral Capsule

Supportive measures

NO INTERVENTION

Supportive only

Interventions

Hydroxycarbamide 500 Mg Oral Capsule+L-CarnitineDRUG

Combination therapy

Also known as: Hydroxyurea+LC
Hydra+L-Carnitine
Hydroxycarbamide 500 Mg Oral CapsuleDRUG

Single agent

Also known as: Hydroxyurea
Hydra only
L-Carnitine, 250 Mg Oral CapsuleDRUG

single agent

Also known as: L-Carnitine
L-Carnitine only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sickle cell disease
  • Not welling for pregnancy in females or to father a baby in males
  • Frequent episodes
  • Non-compliance to transfusion

You may not qualify if:

  • \<18 years
  • Hypersensitivity to hydroxycarbamide or L-Carnitine
  • Pregnancy
  • Other chronic infection or inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safaa A A Khaled

Asyut, 71515, Egypt

Location

Related Publications (5)

  • Bunn HF. Pathogenesis and treatment of sickle cell disease. N Engl J Med. 1997 Sep 11;337(11):762-9. doi: 10.1056/NEJM199709113371107. No abstract available.

    PMID: 9287233BACKGROUND

  • Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.

    PMID: 21131035BACKGROUND

  • Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.

    PMID: 7993409BACKGROUND

  • Kauf TL, Coates TD, Huazhi L, Mody-Patel N, Hartzema AG. The cost of health care for children and adults with sickle cell disease. Am J Hematol. 2009 Jun;84(6):323-7. doi: 10.1002/ajh.21408.

    PMID: 19358302BACKGROUND

  • Elmariah H, Garrett ME, De Castro LM, Jonassaint JC, Ataga KI, Eckman JR, Ashley-Koch AE, Telen MJ. Factors associated with survival in a contemporary adult sickle cell disease cohort. Am J Hematol. 2014 May;89(5):530-5. doi: 10.1002/ajh.23683. Epub 2014 Feb 21.

    PMID: 24478166BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

HydroxyureaCarnitine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAmines

Study Officials

  • Israa EM Ashry, Prof

    Assiut University- Faculty of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 18, 2021

Study Start

January 10, 2017

Primary Completion

June 10, 2020

Study Completion

July 10, 2021

Last Updated

October 22, 2021

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)