Porphozym in the Treatment of Acute Attacks in AIP

Completed · Phase 2/Phase 3

Conditions studied: Acute Intermittent Porphyria

In brief

A multi-centre, double-blind, randomized, placebo controlled, parallel group trial, investigating the efficacy and safety of Porphozym (recombinant human porphobilinogen deaminase)in the treatment of acute attacks in AIP.

Key facts

Study ID

NCT00418795

Run by

Zymenex A/S

People needed

36

Starts

2003-06-11

Expected to finish

2006-06-20

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent
• Confirmed diagnosis of AIP
• Previous attacks with PBG above the reference level of the laboratory AND exclusion of variegate porphyria (florescence emission of plasma samples is maximal at 626 nm in VP) AND exclusion of hereditary coproporphyria (HCP) (increased ratio of fecal coproporphyrin III to coproporphyrin I found in HCP)
• Acute attack of AIP verified by presence of abdominal and/or back and/or limb pain, diagnosed by the investigator as being caused by AIP
• Urine PBG above 6 mmol/mol creatinine (5 times upper reference level of the central laboratory)
• Male or female aged above 18 year
• Exclusion criteria are:
• First acute attack in AIP
• Other reasons for abdominal and/or back and/or limb pain as judged by the investigator
• Therapy with human hemin within 7 days prior to administration of trial drug
• Treatment with any investigational drug within 4 weeks prior to this trial
• Known or suspected allergy to the trial product or related products
• Pregnant or breast-feeding women and women who intend to become pregnant prior to or during the trial
• Women of child-bearing potential who are not using acceptable methods of contraception (systemic contraception, IUD, barrier method or GnRH analogues)
• Previous documented renal impairment defined as above 150 mmol/L or 1.7 mg/dL serum creatinine, indicating a reduction in kidney function of 50% or more
• Any disease or condition that the investigator judges would interfere with the trial
• Previous randomization in this trial

Where it is running

• Univercity Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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