A study to evaluate the safety of Hydroxyurea oral liquid in patients with sickle cell disease.

A Phase IV, Open Label, Multicenter, Prospective study to Assess the Safety and Tolerability of Hydroxyurea Oral Suspension 100mg/ml, in treatment of Sickle Cell Disease Patients (SCD). - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/04/109685

Enrollment

200

Registered

2026-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D578- Other sickle-cell disorders

Interventions

Intervention1: Hydroxyurea 100mg/ml Oral Suspension: Dose: 100 mg/ml Body weight Frequency: once a day Route of administration: Oral Duration of therapy: 90 Days Control Intervention1: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Legally Acceptable Representative (LAR) willing to sign data sharing consent before performing any procedures. 2. Patients of either gender, eligible to receive Hydroxyurea for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Disease (SCD). 3. Patients suitable to participate in the post-marketing Phase-IV study as per Investigator s discretion.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to the active substance (Hydroxyurea) or to any of the excipients. 2. Severe hepatic impairment (Child-Pugh classification C). 3. Severe renal impairment (creatinine clearance less than 30 ml per min). 4. Marked bone marrow depression that is leucopoenia (less than 2.5 WBC to 109 per L) and thrombocytopenia (less than 100 to 109 per L) or severe anaemia. 5. Patient not willing to participate in the study.

Design outcomes

Primary

Measure	Time frame
Adverse events (serious/nonserious, expected/unexpected, related/not related). Adverse events of special interest (leucopenia, neutropenia, thrombocytopenia, reticulocytopenia, skin rash, renal and hepatic toxicity) Clinically abnormal vital signs, physical examination, laboratory investigations at follow up visits.Timepoint: Visit 1: Screening or Baseline visit (day -3) Visit 2: Randomization/ Treatment Intervention (day 1) Visit 3: Treatment period 30 ( 3) days Visit 4: Treatment period 60 ( 7) days Visit 5: Treatment period 90 ( 7) days	—

Measure

Time frame

Adverse events (serious/nonserious, expected/unexpected, related/not related). Adverse events of special interest (leucopenia, neutropenia, thrombocytopenia, reticulocytopenia, skin rash, renal and hepatic toxicity) Clinically abnormal vital signs, physical examination, laboratory investigations at follow up visits.Timepoint: Visit 1: Screening or Baseline visit (day -3) Visit 2: Randomization/ Treatment Intervention (day 1) Visit 3: Treatment period 30 ( 3) days Visit 4: Treatment period 60 ( 7) days Visit 5: Treatment period 90 ( 7) days

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactMr Umakant Ghodke

Pure and Cure Healthcare Pvt Ltd

Mamta.Sharma@akums.net9560695573

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026