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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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2019

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At a glance

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

    • 07 Nov 2019 According to an ObsEva media release, final results from this trial are expected in the second half 2020.
    • 07 Nov 2019 According to an ObsEva media release, interim update in 60 patients dosed in Part B is expected in the fourth quarter of 2019.
    • 07 Nov 2019 According to an ObsEva media release, In July 2019, the independent data monitoring committee (IDMC) recommended continuing the ongoing PROLONG trial with no modifications based upon the first 30 patients enrolled in Part B.
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