Overview
Sponsor-declared trial summary
cytomegalovirus (CMV) infection and/or disease that is refractory (with or without resistance) to one or more prior therapies in adult patients who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT)
Key facts
- Sponsor
- Sun Pharmaceutical Industries Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 5 May 2026 → ongoing
- Decision date (initial)
- 2026-02-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
cytomegalovirus (CMV) infection and/or disease that is refractory (with or without resistance) to one or more prior therapies in adult patients who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sun Pharmaceutical Industries Limited
- Sponsor organisation
- Sun Pharmaceutical Industries Limited
- Address
- Sun House, 1 Plot No 201 B, Western Express Highway, Goregaon East Western Express Highway Goregaon East
- City
- Mumbai
- Postcode
- 400063
- Country
- India
Scientific contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Public contact point
- Organisation
- Sun Pharmaceutical Industries Limited
- Contact name
- Arshad Khuroo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ongoing, recruitment ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Romania | 2026-05-05 | 2026-05-06 | 2026-05-14 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-14 | Romania | Acceptable 2025-12-09
|
2026-02-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Romania | Acceptable 2025-12-09
|
2026-05-06 |