A Phase 3 interventional study of Ravulizumab in Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 9 sites in 6 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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Among 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca — 3 open to participants now, 7 under way, 2 of them phase 3. Hemoglobinuria, Paroxysmal · AstraZeneca.
Among the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca, this one is the 16th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2018, is one of 12 in phase 3, and was the 18th registered.
191 studies on the registry are indexed under Hemoglobinuria, Paroxysmal; 49 are open to participants now.
Browse Hemoglobinuria, Paroxysmal studies →3 of the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca are open now, in 8 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
Alexion Pharmaceuticals, Inc. · Sites in Canada, France, United Kingdom
Ages 12–17
Alexion Pharmaceuticals, Inc. · Sites in United States, Australia, France and 4 more countries
Women only
By country, each count listing its studies:
Of the 30 Hemoglobinuria, Paroxysmal studies recruiting now, 14 (47%) set no upper age limit and 12 (40%) stop at 75 or younger; 12 take children under 18; 4 take healthy volunteers.
This study: Up to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 12 · Phase 4 2
First in 2004; this study’s year is marked. 2 started in 2018.
This study's enrollment of 13 is below the median of 33 across 150 interventional studies indexed under Hemoglobinuria, Paroxysmal.
Median enrollment 26 across the 23 interventional studies, 75 across the 10 observational. Of the 26 that completed or were terminated, 18 (69%) have results posted.
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This study is registered under Alexion Pharmaceuticals, Inc., one of the names counted as AstraZeneca. Under that name alone:
Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.
1 of the studies in Hemoglobinuria, Paroxysmal by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06449001Phase 3Alexion Pharmaceuticals, Inc.Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis | 2027-05-28 |
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Among the 35 studies in Hemoglobinuria, Paroxysmal by AstraZeneca, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).
The study consists of a 4-week Screening Period, a 26-week Primary Evaluation Period, and an Extension Period of up to 4 years (with the exception of any country-specific mandates), whichever occurs first.
Efficacy and safety data are reported for the 26-week Primary Evaluation Period only. Analyses were conducted separately for complement inhibitor treatment-naïve participants and eculizumab-experienced participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Complement inhibitor treatment-naïve and eculizumab-experienced participants received ravulizumab.
Biological: Ravulizumab
Single intravenous (IV) loading dose on Day 1, followed by regular IV maintenance dosing beginning on Day 15, based on weight.
Also known as: ALXN1210, Ultomiris
Maximum Observed Serum Concentration (Cmax) Of Ravulizumab
Blood samples for determination of ravulizumab Cmax were collected before and after administration of study drug at designated time points. Results are reported in micrograms/milliliter (μg/mL).
Time frame: Week 1 (Day 1), Week 2 (Day 15), Week 10 (Day 71), and Week 18 (Day 127)
Trough Serum Concentration (Ctrough) Of Ravulizumab
Blood samples for determination of ravulizumab Ctrough were collected before and after administration of study drug at designated time points. Trough serum concentration was measured at end of dosing interval at steady state. Results are reported in μg/mL.
Time frame: Week 2 (Day 15), Week 10 (Day 71), Week 18 (Day 127), Week 26 (Day 183)
Mean Accumulation Ratio For Cmax Of Ravulizumab Following The Last Maintenance Dose Relative To The First Maintenance Dose
Blood samples for determination of ravulizumab accumulation ratio for Cmax were collected before and after administration of study drug at designated time points. The accumulation ratio was calculated as Cmax from the last maintenance dose (Week 18) divided by Cmax from the first maintenance dose (Week 2).
Time frame: Week 18
Mean Accumulation Ratio For Ctrough Of Ravulizumab Following The Last Maintenance Dose Relative To The First Maintenance Dose
Blood samples for determination of ravulizumab accumulation ratio for Ctrough were collected before and after administration of study drug at designated time points. The accumulation ratio was calculated as Ctrough from the last maintenance dose (Week 18) divided by Ctrough from the first maintenance dose (Week 2).
Time frame: Week 18
Change In Free Complement Component C5 (C5) Concentrations Over Time
Blood samples for determination of free C5 were collected before and after administration of study drug at designated time points.
Time frame: Baseline, Weeks 2, 10, 18, and 26 (end of infusion)
Change In Chicken Red Blood Cell (cRBC) Hemolytic Activity Over Time
Blood samples for determination of cRBC hemolytic activity were collected before and after administration of study drug at designated time points.
Time frame: Baseline, Weeks 2, 10, 18, and 26
Percentage Change From Baseline At Week 26 In Lactate Dehydrogenase (LDH) Levels
Blood and urine samples for determination of LDH levels were collected at designated time points. Baseline was defined as the average of all assessments analyzed by the central laboratory prior to first study drug administration.
Time frame: Baseline, Week 26
Percentage Of Participants Who Achieved Transfusion Avoidance (TA)
Transfusion avoidance was defined as the proportion of participants who remained transfusion-free and did not require a transfusion according to protocol-specified guidelines. Point estimates and 2-sided 95% exact confidence intervals (CIs) were computed. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group needing transfusion. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal was used to assess TA.
Time frame: Week 26
Change In Quality Of Life (QoL) From Baseline To Week 26
Quality of life was measured by Pediatric Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire (participants ≥ 5 years of age), a 13-item questionnaire that assesses fatigue and its impact upon daily activities and function over the preceding 7 days. Each item is scored on a 5-point scale, and total scores range from 0 to 52, with a higher score indicating better QoL. The scoring guideline for the Pediatric FACIT-Fatigue instrument was used to calculate a FACIT-Fatigue score. Changes from baseline in FACIT-Fatigue scores were summarized at baseline and at the study visits where this assessment was collected up to Day 183 (Week 26). At each study visit, the proportion of participants who showed an improvement of at least 3 points for the Pediatric FACIT-Fatigue scores were summarized by point estimates and 2-sided 95% exact CIs.
Time frame: Baseline, Week 26
Percentage Of Participants With Stabilized Hemoglobin At Week 26
Stabilized hemoglobin was defined as avoidance of a ≥ 2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion through Week 26. Point estimates and 2-sided 95% exact CIs were computed. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group who did not meet the stabilized hemoglobin definition. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal were used to assess stabilized hemoglobin.
Time frame: Week 26
Percentage Change In Free Hemoglobin From Baseline To Week 26
Percentage change from baseline in free hemoglobin was summarized at all study visits up to Day 183 (Week 26). Baseline was defined as the last non-missing assessment value prior to the first study drug infusion.
Time frame: Baseline, Week 26
Percentage Of Participants With Breakthrough Hemolysis (BTH) At Week 26
Breakthrough hemolysis was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia, major adverse vascular event \[including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH as follows: for participants who entered the study naïve to complement inhibitor treatment, elevated LDH ≥ 2 × the upper limit of normal (ULN) after prior LDH reduction to \< 1.5 × ULN on therapy; for participants who entered the study stabilized on eculizumab treatment, elevated LDH ≥ 2 × ULN. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group with BTH. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal were used to assess BTH. No participants experienced BTH.
Time frame: Week 26
Thirteen participants, from birth to \< 18 years, were planned to be enrolled to ensure at least 10 evaluable participants would complete the 26-week Primary Evaluation Period. Participants were recruited from 9 sites across 6 countries (United States, United Kingdom, France, Netherlands, Russia, and Norway).
| Milestone | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Started | 5 | 8 |
| Received at least 1 dose of study drug | 5 | 8 |
| Completed | 5 | 8 |
| Not completed | 0 | 0 |
| Milestone | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Started | 5 | 8 |
| Received at least 1 dose of study drug | 5 | 8 |
| Completed | 5 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
Blood samples for determination of ravulizumab Cmax were collected before and after administration of study drug at designated time points. Results are reported in micrograms/milliliter (μg/mL).
| μg/mL | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Day 1: End of Infusion | 725.40 ± 93.730 | 884.63 ± 170.842 |
| Day 15: End of Infusion | 1161.60 ± 254.348 | 1612.50 ± 211.441 |
| Day 71: End of Infusion | 1402.00 ± 344.267 | 1581.43 ± 207.961 |
| Day 127: End of Infusion | 1396.00 ± 403.770 | 1705.00 ± 164.751 |
Blood samples for determination of ravulizumab Ctrough were collected before and after administration of study drug at designated time points. Trough serum concentration was measured at end of dosing interval at steady state. Results are reported in μg/mL.
| μg/mL | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Day 15: Predose | 358.20 ± 51.978 | 452.25 ± 68.312 |
| Day 71: Predose | 370.20 ± 134.267 | 521.00 ± 72.870 |
| Day 127: Predose | 410.80 ± 215.503 | 554.88 ± 60.976 |
| Day 183: Predose | 419.00 ± 191.921 | 565.63 ± 68.980 |
Blood samples for determination of ravulizumab accumulation ratio for Cmax were collected before and after administration of study drug at designated time points. The accumulation ratio was calculated as Cmax from the last maintenance dose (Week 18) divided by Cmax from the first maintenance dose (Week 2).
| Ratio | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Mean Accumulation Ratio For Cmax Of Ravulizumab Following The Last Maintenance Dose Relative To The First Maintenance Dose | 1.1995 ± 0.21038 | 1.0630 ± 0.06872 |
Blood samples for determination of ravulizumab accumulation ratio for Ctrough were collected before and after administration of study drug at designated time points. The accumulation ratio was calculated as Ctrough from the last maintenance dose (Week 18) divided by Ctrough from the first maintenance dose (Week 2).
| Ratio | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Mean Accumulation Ratio For Ctrough Of Ravulizumab Following The Last Maintenance Dose Relative To The First Maintenance Dose | 1.2208 ± 0.32490 | 1.0700 ± 0.09089 |
Blood samples for determination of free C5 were collected before and after administration of study drug at designated time points.
| ug/mL | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Week 2 | -105.319 ± 17.1118 | 0.000 ± 0.0000 |
| Week 10 | -105.310 ± 17.1139 | 0.003 ± 0.0052 |
| Week 18 | -105.320 ± 17.1165 | 0.006 ± 0.0067 |
| Week 26 | -105.320 ± 17.1184 | 0.006 ± 0.0070 |
Blood samples for determination of cRBC hemolytic activity were collected before and after administration of study drug at designated time points.
| percentage of hemolysis | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Week 2 | -93.12 ± 9.259 | 1.95 ± 2.816 |
| Week 10 | -93.24 ± 9.241 | 3.97 ± 9.209 |
| Week 18 | -96.93 ± 4.543 | 2.78 ± 5.673 |
| Week 26 | -96.78 ± 4.816 | 7.03 ± 12.680 |
Blood and urine samples for determination of LDH levels were collected at designated time points. Baseline was defined as the average of all assessments analyzed by the central laboratory prior to first study drug administration.
| Percent Change | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Percentage Change From Baseline At Week 26 In Lactate Dehydrogenase (LDH) Levels | -47.91 ± 52.716 | 4.65 ± 44.702 |
Transfusion avoidance was defined as the proportion of participants who remained transfusion-free and did not require a transfusion according to protocol-specified guidelines. Point estimates and 2-sided 95% exact confidence intervals (CIs) were computed. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group needing transfusion. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal was used to assess TA.
| Percentage of Participants | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Percentage Of Participants Who Achieved Transfusion Avoidance (TA) | 60.00 (14.66 to 94.73) | 100.00 (63.06 to 100.00) |
Quality of life was measured by Pediatric Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Questionnaire (participants ≥ 5 years of age), a 13-item questionnaire that assesses fatigue and its impact upon daily activities and function over the preceding 7 days. Each item is scored on a 5-point scale, and total scores range from 0 to 52, with a higher score indicating better QoL. The scoring guideline for the Pediatric FACIT-Fatigue instrument was used to calculate a FACIT-Fatigue score. Changes from baseline in FACIT-Fatigue scores were summarized at baseline and at the study visits where this assessment was collected up to Day 183 (Week 26). At each study visit, the proportion of participants who showed an improvement of at least 3 points for the Pediatric FACIT-Fatigue scores were summarized by point estimates and 2-sided 95% exact CIs.
| units on a scale | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Change In Quality Of Life (QoL) From Baseline To Week 26 | 3.40 ± 6.107 | 1.28 ± 5.235 |
Stabilized hemoglobin was defined as avoidance of a ≥ 2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion through Week 26. Point estimates and 2-sided 95% exact CIs were computed. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group who did not meet the stabilized hemoglobin definition. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal were used to assess stabilized hemoglobin.
| Percentage of Participants | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Percentage Of Participants With Stabilized Hemoglobin At Week 26 | 60.0 (14.66 to 94.73) | 75.0 (34.91 to 96.81) |
Percentage change from baseline in free hemoglobin was summarized at all study visits up to Day 183 (Week 26). Baseline was defined as the last non-missing assessment value prior to the first study drug infusion.
| Percentage Change | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Percentage Change In Free Hemoglobin From Baseline To Week 26 | 87.32 ± 226.816 | -15.29 ± 71.780 |
Breakthrough hemolysis was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath \[dyspnea\], anemia, major adverse vascular event \[including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated LDH as follows: for participants who entered the study naïve to complement inhibitor treatment, elevated LDH ≥ 2 × the upper limit of normal (ULN) after prior LDH reduction to \< 1.5 × ULN on therapy; for participants who entered the study stabilized on eculizumab treatment, elevated LDH ≥ 2 × ULN. Participants who withdrew from the study due to lack of efficacy during the Primary Evaluation Period were considered as non-responders and were counted in the group with BTH. For participants who withdrew from the study for any other reason during the Primary Evaluation Period, their data up to the time of withdrawal were used to assess BTH. No participants experienced BTH.
| Participants | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Percentage Of Participants With Breakthrough Hemolysis (BTH) At Week 26 | 0 | 0 |
Collected over Day 1 through End of Study (Up to Day 1610). Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Naïve | 0/5 (0%) | 2/5 (40%) | 4/5 (80%) |
| Eculizumab Experienced | 0/8 (0%) | 2/8 (25%) | 7/8 (87.5%) |
| Event | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| Device related thrombosisGeneral disorders | 1/5 | 0/8 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/5 | 0/8 |
| Device related sepsisInfections and infestations | 1/5 | 0/8 |
| Septic shockInfections and infestations | 1/5 | 0/8 |
| Staphylococcal infectionInfections and infestations | 1/5 | 0/8 |
| Aplastic anaemiaBlood and lymphatic system disorders | 1/5 | 0/8 |
| Viral upper respiratory tract infectionInfections and infestations | 0/5 | 1/8 |
| Breakthrough haemolysisBlood and lymphatic system disorders | 0/5 | 1/8 |
| InfluenzaInfections and infestations | 0/5 | 1/8 |
| Event | Treatment Naïve | Eculizumab Experienced |
|---|---|---|
| COVID-19Infections and infestations | 2/5 | 1/8 |
| Abdominal painGastrointestinal disorders | 0/5 | 3/8 |
| NauseaGastrointestinal disorders | 0/5 | 3/8 |
| Abdominal pain upperGastrointestinal disorders | 0/5 | 3/8 |
| ConstipationGastrointestinal disorders | 0/5 | 2/8 |
| FatigueGeneral disorders | 0/5 | 2/8 |
| NasopharyngitisInfections and infestations | 1/5 | 2/8 |
| Upper respiratory tract infectionInfections and infestations | 0/5 | 2/8 |
| Urinary tract infectionInfections and infestations | 0/5 | 2/8 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 0/5 | 2/8 |
Full Analysis: all participants who received at least 1 dose of ravulizumab and had at least 1 efficacy assessment after the first infusion of ravulizumab.
| Age, Continuous(years) | Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Mean | 14.4 ± 2.19 | 14.4 ± 3.07 | 14.4 ± 2.66 |
| Sex: Female, Male(Participants) | Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Female | 1 | 7 | 8 |
| Male | 4 | 1 | 5 |
| Race/Ethnicity, Customized(Participants) | Treatment Naïve | Eculizumab Experienced | Total |
|---|---|---|---|
| Race - Undisclosed | 5 | 8 | 13 |
| Ethnicity - Undisclosed | 5 | 8 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Feb 2018 to primary completion in Mar 2020, 25 months.
Results were first posted in May 2022, 2 years 1 month after primary completion.
Of 35 industry-sponsored phase 3 interventional studies under Hemoglobinuria, Paroxysmal, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 41. This study's 25 months is close to that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 15 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ravulizumab
Alexion Pharmaceuticals, Inc. →