WHO ICTRP trial
Study to evaluate the safety and efficacy of Flebogamma 5% DIF in patients with…
EUCTR2013-004503-39-IT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2013-004503-39-IT |
|---|---|
| Public title | Study to evaluate the safety and efficacy of Flebogamma 5% DIF in patients with Post-Polio Syndorme |
| Scientific title | A multicenter, prospective, randomized, placebo-controlled, double-blind, parallel-group clinical trial to assess the efficacy and safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in patients with Post-Polio Syndrome |
| Primary sponsor | Instituto Grifols, S.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Countries | United States;Canada;Poland;Spain;Romania;Denmark;Netherlands;Germany;Italy;Sweden |
| Conditions | Patients with Post-polio syndrome MedDRA version: 17.0 Level: PT Classification code 10036239 Term: Post polio syndrome System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: SOC Classification code 10029205… |
| Interventions | Trade Name: Flebogamma DIF 50 mg/ml - 200 ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human normal immunoglobulin (IVIg) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: mg/ml… |
| Registration date | Jun 10, 2014 |
| Target size | 210 |
| Secondary IDs | IG1104 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: