Phase 3 Cystic Fibrosis Trial, Recruiting NCT07616375 Sponsor: Haisco Pharmaceutical Group Co., Ltd. Condition: Cystic Fibrosis
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Phase 3 Cystic Fibrosis Trial, Recruiting

NCT07616375
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to take part and have signed a consent form agreeing to join the study
  • You previously took part in the HSK31858-301 study, completed the randomisation process, and received at least the first dose of the study medication
  • If you regularly use long-acting breathing/airway medications, your dose and schedule must have stayed the same and must remain unchanged throughout this study
  • Women must either be past menopause, have had surgery that prevents pregnancy, or be using a highly reliable form of contraception from the first day of the study until at least 30 days after the last dose
  • Men whose female partners could become pregnant must use effective contraception from the first day of the study until at least 90 days after the last dose

Who may not be able to join:

  • You had a serious side effect in the HSK31858-301 study that was linked to the study drug, or the study doctors decided you needed to permanently stop taking the treatment
  • You have any other unstable health condition — such as heart, digestive, liver, kidney, nerve, bone/muscle, infection, hormone, blood, or mental health problems — that the study doctor believes could put you at risk, affect the study results, or prevent you from completing the full study
  • You are currently pregnant or breastfeeding
  • The study doctors have decided for any other reason that joining the study would not be appropriate for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 86-13826042052

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
Registry
ClinicalTrials.gov
Start date
28 September 2025
Est. completion
10 January 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

AE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov