A Study to Evaluate the dose and Safety of purified Human Chorionic Gonadotropin (hCG) injection in Patients with post bone marrow transplant Acute Graft-versus-Host Disease

An Open-label, Single-arm, Phase-1 Clinical study to evaluate the safety of purified Human Chorionic Gonadotrophin in patients with acute Graft vs Host disease - nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093298

Enrollment

Registered

2025-08-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified

Interventions

Intervention1: Drug purified human chorionic gonadotrophin: Subcutaneous injection, every alternate day total 7 doses followed by twice weekly maintenance Control Intervention1: Single arm not applica

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Grade II or more GVHD AGE 18 to 65

Exclusion criteria

Exclusion criteria: Patients with thrombosis within 3 months of starting the study, a current thromboembolic disease requiring full dose anticoagulation. c) Progressive malignancy d) Previous diagnosis of hormone-responsive malignancy e) Pregnancy f) Uncontrolled infection at the initiation of protocol

Design outcomes

Primary

Measure	Time frame
To determine the toxicity and maximum tolerated dose of purified human chorionic gonadotrophinTimepoint: toxicity assessment will be ongoing for 8 weeks post first injection. visits are scheduled on Day 4,7, 14, 28, 56.	—

Secondary

Measure	Time frame
To determine the efficacy of HCG(purified) & proportional response among patientsTimepoint: response to therapy on day7, day 14, day 28, day 56 as compared to baseline	—

Countries

India

Contacts

Public ContactDr Talasila Naga Bhavani Krishna

All india institute of medical sciences

drranjitmd@gmail.com9013956187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026