A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour

Trial Profile

A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour

Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Aug 2018

At a glance

  • Drugs OBE 022 (Primary)
  • Indications Preterm labour
  • Focus Proof of concept; Therapeutic Use
  • Acronyms PROLONG
  • Sponsors ObsEva
  • Most Recent Events

    • 08 Aug 2018 According to an ObsEva media release, patient enrollment continued in Part A of this study and is presently completing.Also, positive pharmacokinetic data support moving to Part B of the trial.Initial interim efficacy data from Part B of the trial continues to be expected in Q4 of 2018.
    • 16 May 2018 According to an ObsEva media release, interim efficacy results form this trial are expected in Q4: 2018
    • 05 Dec 2017 According to an ObsEva media release, part A of the trial is being conducted in Finland at the Helsinki University Women's Hospital, under the supervision of Professor Seppo Heinonen, the Director of Obstetrics and Gynaecology. The company expects to announce preliminary results from 60 patients in Part B in late 2018.
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