A study to see whether genetic testing can help reduce side effects of azathioprine treatment

Effectiveness of genomic-guided dose optimization in prevention of Azathioprine induced myelosuppression in eastern India: A prospective study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109462

Enrollment

150

Registered

2026-04-27

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: K754- Autoimmune hepatitis Health Condition 2: K509- Crohns disease, unspecified Health Condition 3: M064- Inflammatory polyarthropathy Health Condition 4: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: TPMT (rs1800462) and NUDT15 (rs116855232) gene polymorphisms screening guided azathioprine dosing: Genetic screening guided dose modification of azathioprine and review after 3 months.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged more than 18 years prescribed azathioprine 2. No prior exposure to thiopurines (azathioprine, mercaptopurine, or thioguanine).

Exclusion criteria

Exclusion criteria: 1. Patients on concomitant myelosuppressive medications. 2. Patients with pre-existing or have a positive family history of hematological disorders. 3. History of severe adverse reactions to thiopurines. 4. Patients with recent infections affecting cell counts in hemogram. 5. Pregnant and lactating mothers.

Design outcomes

Primary

Measure	Time frame
Incidence of azathioprine-induced myelosuppression within 3 months, comparing patients who received early genetic testing guided dosing with those who received standard treatment without initial genetic testing.Timepoint: At 3 months post-treatment.	—

Secondary

Measure	Time frame
Proportion of patients requiring dose adjustments based on clinical toxicity and laboratory parameters.Timepoint: At the end of the study;Time to onset of myelosuppression in patients who develop toxicity despite dose optimization.Timepoint: At the end of the study;Rate of therapy discontinuation due to adverse drug reactions, including myelosuppression, hepatotoxicity, or gastrointestinal intolerance.Timepoint: At the end of the study;Frequency and severity of other adverse drug reactions (e.g., hepatotoxicity, pancreatitis, mucositis, alopecia, rash, furuncles, etc.) in both study groups.Timepoint: At the end of the study	—

Measure

Time frame

Proportion of patients requiring dose adjustments based on clinical toxicity and laboratory parameters.Timepoint: At the end of the study;Time to onset of myelosuppression in patients who develop toxicity despite dose optimization.Timepoint: At the end of the study;Rate of therapy discontinuation due to adverse drug reactions, including myelosuppression, hepatotoxicity, or gastrointestinal intolerance.Timepoint: At the end of the study;Frequency and severity of other adverse drug reactions (e.g., hepatotoxicity, pancreatitis, mucositis, alopecia, rash, furuncles, etc.) in both study groups.Timepoint: At the end of the study

—

Countries

India

Contacts

Public ContactDr Tirthankar Deb

AIIMS, Kalyani

tirthankar.pharma@aiimskalyani.edu.in9088859953

Outcome results

None listed

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