Riociguat for Sarcoidosis Associated Pulmonary Hypertension

NCT02625558 | Unknown Phase 4 DMC

• 1 other identifier: 2014-7130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary hypertension

Conditions

Sarcoidosis

Keywords

riociguat; saph; sarcoidosis; sarcoidosis associated pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Time until clinical worsening

  Patient shows deterioration using fixed criteria

  48 weeks

Secondary Outcomes (4)

• Safety: adverse events

  48 weeks

• Pulmonary function

  48 weeks

• Quality of life

  48 weeks

• Six minute walk

  48 weeks

Study Arms (2)

Riociguat

ACTIVE COMPARATOR

Active drug

Drug: Riociguat

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Riociguat DRUG

Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day

Also known as: Rio

Riociguat

Placebo DRUG

Placebo given three times a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosis of sarcoidosis
• Age ≥ 18 years.
• Life expectancy of at least 2 years.
• Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
• Females of reproductive potential (FRP) must have a negative, pre-treatment pregnancy test.
• FRP must obtain monthly pregnancy tests during treatment and one month after treatment discontinuation. Post-menopausal women (defined as no menses for at least 1 year or post-surgical from bilateral oophorectomy) and surgically sterilized women are not required to undergo a pregnancy test.
• Females of reproductive potential and all non-vasectomized male participants must agree to use reliable contraception when sexually active.
• Subjects (males and females) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug.
• Willing and able to comply with the protocol, including follow-up visits and examinations

You may not qualify if:

• Patients with an FVC of less than 30% of predicted during screening visit.
• Patients with severe airway obstruction
• Patients unable to perform the 6 minute walk test
• Pregnant women (i.e. positive serum ß-human chorionic gonadotropin test or other signs of pregnancy),
• Breast feeding women
• FRP not using reliable contraception as recommended in the Prescriber Guide for the riociguat pregnancy monitoring program
• Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
• Known significant left heart disease:
• Pulmonary venous hypertension indicated by baseline pulmonary capillary wedge pressure \> 15 mmHg
• Active state or history of hemoptysis or pulmonary hemorrhage
• Subjects requiring nitrates for any reason
• Subject using nitrates within one month of entering study
• Pulmonary veno-occlusive disease
• Subjects with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumor).
• Subjects with hypersensitivity to the investigational drug or any of the excipients.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (1)

• Baughman RP, Shlobin OA, Gupta R, Engel PJ, Stewart JI, Lower EE, Rahaghi FF, Zeigler J, Nathan SD. Riociguat for Sarcoidosis-Associated Pulmonary Hypertension: Results of a 1-Year Double-Blind, Placebo-Controlled Trial. Chest. 2022 Feb;161(2):448-457. doi: 10.1016/j.chest.2021.07.2162. Epub 2021 Aug 4.

  PMID: 34363816 DERIVED

MeSH Terms

Conditions

Sarcoidosis

Interventions

riociguat

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Robert P Baughman, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Steve Nathan, MD

  Inova Fairfax Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert P Baughman, MD

CONTACT

513-584-5225; bob.baughman@uc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: December 9, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 9, 2015

Record last verified: 2015-12

Locations

US (1)