# A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia

> **NCT07345000** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Qilu Pharmaceutical Co., Ltd.** · enrollment: 210 (estimated)

## Conditions studied

- Treatment-naïve Severe Aplastic Anemia

## Interventions

- **DRUG:** Romiplostim N01
- **DRUG:** Cyclosporine A (CsA)
- **DRUG:** pALG/ rATG
- **DRUG:** Placebo
- **DRUG:** Cyclosporine A (CsA)
- **DRUG:** pALG/ rATG

## Key facts

- **NCT ID:** NCT07345000
- **Lead sponsor:** Qilu Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-01
- **Primary completion:** 2029-10
- **Final completion:** 2030-08
- **Target enrollment:** 210 (ESTIMATED)
- **Last updated:** 2026-01-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07345000

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07345000, "A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT07345000. Licensed CC0.

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