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SarcoidosisPhase 4RioSAPHNCT02625558

Riociguat for Sarcoidosis Associated Pulmonary Hypertension

A Phase 4 study testing Riociguat in people with Sarcoidosis, run by University of Cincinnati at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Double blind placebo controlled trial of riociguat for sarcoidosis associated pulmonary hypertension Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoidosis
What is being tested?
Riociguat
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Apr 2015to Oct 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.
  • Women who are pregnant or breast-feeding.
  • Severe proven or suspected coronary artery disease
  • Clinical relevant hepatic dysfunction indicated by: bilirubin >2 times upper limit normal at Visit 0 and/or: alanine aminotransferase (ALT) or AST aspartate aminotransferase (AST) >3 times upper limit normal at Visit 0 and/or: signs of severe hepatic insufficiency (e.g. impaired albumin synthesis with an albumin <32 g/L, hepatic encephalopathy > grade 1a) at Visit 0
  • West Haven Criteria of Altered Mental Status in Hepatic Encephalopathy
  • Severe renal insufficiency indicated by a glomerular filtration rate <30 mL/min at Visit 0, e.g. calculated based on the Cockcroft formula or the Modification of Diet in Renal Disease Study Group (MDRD) formula
  • Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Excluded therapies and medications, previous and concomitant
  • Specific (e.g. sildenafil or tadalafil) or unspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline).
  • NO donors (e.g. nitrates). Single applications of vasoactive drugs in connection with diagnostic vasoreactive testing are allowed.
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
  • Major surgery within 30 days prior to start of study drug.

Trial locations and contacts

1 site in 1 country.

Robert P Baughman, MD contact

513-584-5225

bob.baughman@uc.edu

United States1 site, 1 recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45267

    Felicia Thompson, 513-584-6252, THOMPSFA@ucmail.uc.edu

    Robert P Baughman, MD

    Recruiting

Other trials in United States

About this study

Official title: A Double Blind, Placebo Controlled Trial of Oral Riociguat for Sarcoidosis Associated Pulmonary Hypertension

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

Read the detailed description

Study design Patients will be recruited into double blind randomized trial of riociguat with 1:1 active drug to placebo. The table below summarizes the study design. Patients will have previously undergone right heart catheterization (RHC) within six months of initial dose dispensation and with no significant change in treatment for pulmonary hypertension. Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day.

The patient will be treated for 48 weeks or until clinical worsening of disease. An adjudication committee will review all cases of clinical worsening. This committee will be blinded to treatment. The determination by the adjudication committee will be used as the final determinant for the primary end point.

Conditions
Sarcoidosis
Being tested
Riociguat, Placebo
Keywords
riociguat, saph, sarcoidosis, sarcoidosis associated pulmonary hypertension
Medical subject headings
Sarcoidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RiociguatDrug

    Also called Rio

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

  • PlaceboDrug

    Placebo given three times a day

Study groups in NCT02625558
Study groupRoleWhat they receive
RiociguatActive comparatorActive drug
Receives: Drug: Riociguat
PlaceboPlacebo comparatorplacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time until clinical worsening

    Patient shows deterioration using fixed criteria

    Measured: 48 weeks

Secondary outcomes (4)

  1. Safety: adverse events

    adverse events

    Measured: 48 weeks

  2. Pulmonary function

    Changes in FVC

    Measured: 48 weeks

  3. Quality of life

    Changes in QOL using general and sarcoidosis specific instruments

    Measured: 48 weeks

  4. Six minute walk

    Change in six minute walk distance

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625558
Sponsor's protocol ID
2014-7130
Acronym
RioSAPH
Status last verified
Dec 2015
First submitted
26 May 2015
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34363816

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Riociguat in people with Sarcoidosis, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Robert P Baughman, MD (513-584-5225, bob.baughman@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time until clinical worsening (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.

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