WHO ICTRP trial
A six weeks versus six months Study of oral valgancoclovir medicine and dummy…
EUCTR2008-005508-14-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2008-005508-14-GB |
|---|---|
| Public title | A six weeks versus six months Study of oral valgancoclovir medicine and dummy medicine in infants with congenital cytomegalovirus infection symtoms. |
| Scientific title | A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-0046 (CASG 112) - CASG 112 |
| Primary sponsor | University College london |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;United Kingdom |
| Conditions | Symptomatic Congenital Cytomegalovirus. MedDRA version: 14.1 Level: PT Classification code 10010430 Term: Congenital cytomegalovirus infection System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area… |
| Interventions | Trade Name: Valcyte 50 mg/ml Powder for Oral Solution Product Name: Valganciclovir Pharmaceutical Form: Oral solution INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE CAS Number: 175865-59-5 Current Sponsor code: 08/0171 Concentration… |
| Registration date | Mar 15, 2010 |
| Target size | 104 |
| Secondary IDs | 08/0171 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: