WHO ICTRP trial
The purpose of this study is to demonstrate that CT-P10 (the drug under…
EUCTR2013-004493-96-GR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2013-004493-96-GR |
|---|---|
| Public title | The purpose of this study is to demonstrate that CT-P10 (the drug under investigation) works as effectively and safely as Rituxan in Patients with untreated advanced follicular lymphoma. The study is also investigating the pharmacokinetic similarity (the amount of drug or its breakdown in the body over a period of time) and the pharmacodynamics (the effect a drug has on the body), and overall safety and efficacy of CT-P10 in comparison with Rituxan. |
| Scientific title | A Phase 1/3, Randomised, Parallel-Group, Active-Controlled, Double-Blind Study to Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan, Each Administered in Combination With Cyclophosphamide, Vincristine, and Prednisone (CVP) in Patients… |
| Primary sponsor | CELLTRION, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Belarus;Portugal;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Russian Federation;Italy;India;Mexico;Brazil;Poland;Romania;Bulgaria;South Africa;Georgia;Netherlands;Korea, Republic of |
| Conditions | Advanced Follicular Lymphoma MedDRA version: 16.1 Level: PT Classification code 10016910 Term: Follicle centre lymphoma, follicular grade I, II, III stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl… |
| Interventions | Product Name: CT-P10 Product Code: CT-P10 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Current Sponsor code: CT-P10 Concentration unit: mg milligram(s) Concentration type… |
| Registration date | Apr 2, 2014 |
| Target size | 250 |
| Secondary IDs | CT-P10-3.3;2013-004493-96-NL |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: