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Trial · NCT03338816

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Annualized Rate of Porphyria Attacks in Participants With Acute Intermittent Porphyria (AIP)Placebo12.5295% Confidence Interval 9.35 to 16.76annualized attack rate
Annualized Rate of Porphyria Attacks in Participants With Acute Intermittent Porphyria (AIP)Givosiran 2.5 mg/kg3.2295% Confidence Interval 2.25 to 4.59annualized attack rate
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIPPlaceboMonth 319.965Standard Error 1.475mmol/mol creatinine (Cr)
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIPGivosiran 2.5 mg/kgMonth 31.756Standard Error 1.413mmol/mol creatinine (Cr)
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIPPlaceboMonth 623.150Standard Error 2.534mmol/mol creatinine (Cr)
The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIPGivosiran 2.5 mg/kgMonth 64.013Standard Error 2.352mmol/mol creatinine (Cr)
The PD Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) in Participants With AIPPlacebo49.110Standard Error 4.959mmol/mol Cr
The PD Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) in Participants With AIPGivosiran 2.5 mg/kg12.906Standard Error 4.642mmol/mol Cr
Annualized Rate of Hemin Administration in Participants With AIPPlacebo29.7195% Confidence Interval 18.41 to 47.94annualized rate of use
Annualized Rate of Hemin Administration in Participants With AIPGivosiran 2.5 mg/kg6.7795% Confidence Interval 4.20 to 10.92annualized rate of use
Annualized Rate of Porphyria Attacks in Participants With AHPPlacebo12.2695% Confidence Interval 9.22 to 16.29annualized attack rate
Annualized Rate of Porphyria Attacks in Participants With AHPGivosiran 2.5 mg/kg3.3595% Confidence Interval 2.37 to 4.74annualized attack rate
Area Under the Curve (AUC) of the Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP
Placebo5.286Inter-Quartile Range -23.048 to 11.145score on a scale*week
Area Under the Curve (AUC) of the Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP
Givosiran 2.5 mg/kg-11.514Inter-Quartile Range -29.181 to 3.040score on a scale*week
Average Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIPPlacebo0.245Inter-Quartile Range -1.020 to 0.470score on a scale
Average Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIPGivosiran 2.5 mg/kg-0.506Inter-Quartile Range -1.309 to 0.143score on a scale
AUC of the Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIPPlacebo-4.208Standard Error 4.689score on a scale*week
AUC of the Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIPGivosiran 2.5 mg/kg-11.148Standard Error 4.501score on a scale*week
Average Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIPPlacebo-0.182Standard Error 0.209score on a scale
Average Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIPGivosiran 2.5 mg/kg-0.502Standard Error 0.200score on a scale

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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