WHO ICTRP trial
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study…
EUCTR2011-004590-90-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2011-004590-90-DE |
|---|---|
| Public title | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium difficile toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium difficile toxin B), and MK-3415A (Human Monoclonal Antibodies to Clostridium difficile toxin A and toxin B) in Patients Receiving Antibiotic Therapy for Clostridium difficile Infection |
| Scientific title | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of the Efficacy, Safety, and Tolerability of a Single Infusion of MK-3415 (Human Monoclonal Antibody to Clostridium difficile toxin A), MK-6072 (Human Monoclonal Antibody to Clostridium difficile toxin B), and MK-3415A… |
| Primary sponsor | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Portugal;United States;Spain;Austria;Israel;Chile;Colombia;Italy;United Kingdom;India;Czech Republic;Mexico;Puerto Rico;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;New Zealand |
| Conditions | recurrence of Clostridium difficile infection (CDI) MedDRA version: 14.1 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C]… |
| Interventions | Product Code: MK-3415 Pharmaceutical Form: Solution for injection INN or Proposed INN: NA CAS Number: NA Current Sponsor code: MK-3415 Other descriptive name: MK-3415 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal… |
| Registration date | Nov 22, 2011 |
| Target size | 1600 |
| Secondary IDs | 3415A-001 |
| 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: