NL-OMON54663
Recruiting
Phase 2
A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Variegate Porphyria (VP)-related skin disease. - Phase IIa VP Study / CUV040
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clinuvel (UK) LTD
- Enrollment
- 3
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients with confirmed diagnosis of VP.
- •Patients with VP\-related skin symptoms assessed with a score equal or above 7
- •on the 11\-point VAS IGA.
Exclusion Criteria
- •Known allergy to afamelanotide or the polymer or to lignocaine/lidocaine or
- •other local anaesthetic.
- •Had two or more acute attacks of hepatic porphyria lasting more than two days,
- •within 12 months prior to the Screening period.
- •History of certain malignant and premalignant skin lesions.
- •Individual or family history of melanoma.
- •Severe hepatic disease.
- •Renal impairment (eGFR (MDRD) \< 30 ml/min\*1\.73m2\).
- •Female who is pregnant or lactating.
- •Females of child\-bearing potential not using adequate contraceptive measures.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
An Open- Label, Phase 2, Multicenter Feasibility Study if Manualized MDMA-Assisted Psychotherapy with an fMRI sub-study Assessing Changes in Brain Activity in Subjects with Post-Traumatic Stress DisorderNL-OMON56347MAPS Europe B.V.8
Completed
Phase 2
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1.Primary Hyperoxaluria Type 1metabolic disorders10038430NL-OMON50391Alnylam Pharmaceuticals, Inc2
Completed
Phase 2
A phase I/II study evaluating the safety and activity of Pegylated recombinant human Arginase (BCT-100) in Relapsed/refractory cancers of Children and young adultsonbehandelbare en/of terugkerende vorm van kanker: leukemie, hoogradig glioom, neuroblastoom, sarcoomrelapsed or refractory cancer10027655NL-OMON49172Cancer Research UK Clinical Trials Unit4
Completed
Not Applicable
An open-label, explorative, post launch, multicenter, multi-country intervention study of PKU Synergy (an amino-acid mixture) to evaluate change in nutrient intake in PKU subjects with an increased Phe-tolerance/intake.NL-OMON48912utricia Research2
Completed
Not Applicable
A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart FailureCardiac FailureHeart Failure10019280NL-OMON51726van de Wetering CRC2